A Phase 2 interventional study of Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato] in HIV Infections, sponsored by Fundacion SEIMC-GESIDA. Completed at 17 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Fundacion SEIMC-GESIDA · Phase 2, Interventional, and Treatment
Dolutegravir (DTG) plus lamivudine (3TC) is a dual regimen combination recommended for both naïve and suppressed persons with HIV-1 infection1. However, data regarding the efficacy of this regimen in suppressed persons with history of past resistance or virologic failures is currently insufficient. This is a phase IIa, open-label, single arm, multicentric study.
The hypothesis is that therapy with DTG/3TC would be able to maintain viral control in HIV infected participants with prior history of 3TC resistance but without evidence of M184V/I resistance mutation in proviral DNA population sequencing at baseline. The investigators also hypothesize that archived minority 3TC resistance associated mutations detected by next-generation (NGS) sequencing prior to the switch would not have a significant impact on the efficacy of DTG/3TC.
This is a multicentre study, and it will be conducted at different healthcare centres in Spain. 117 participants will be recruited. A minimum of 30%-50% of the study population would be required to have historical RNA population genotype with confirmed M184V/I mutation.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 167 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Fundacion SEIMC-GESIDA is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stable ART in the 12 weeks prior to screening visit.
- Only switch for tolerability/convenience/access reasons to generic drugs or switch from ritonavir to cobicistat or TDF to TAF would be allowed in the 12-week window and as long as the components of the regimen are unchanged.
Viral load \<50 copies/mL at screening and in the year prior to study entry.
- A blip (50-500 copies/ml) would be allowed within 48 weeks prior to inclusion in the study, if preceded and followed by an undetectable VL determination.
History of 3TC resistance: either confirmed historical 3TC resistance (historical RNA Sanger or RNA NGS>20% threshold genotype with M184V/I mutation) OR suspected historical 3TC resistance.
i. Previous treatment with only 2 NRTIs (1 of them being emtricitabine or 3TC [XTC]).
ii. Two consecutive VL > 200 cp/mL while on treatment including XTC. iii. One VL > 200 cp/mL while on treatment including XTC PLUS change of ART as consequence of that elevated VL.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment: Dolutegravir 50 mg/Lamivudine 300 mg, one film coated-tablet once daily during 96 weeks
Drug: Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]
Drug pages: Dolutegravir · Dolutegravir Sodium/Lamivudine
change of current antiretroviral treatment to DTG 50 mg/3TC 300 mg QD
The Efficacy of a Switch to DTG/3TC for Maintenance of Virologic Suppression, in Persons With Past Confirmed or Suspected 3TC Resistance, When Proviral DNA Population Sequencing Does Not Detect 3TC Resistance-associated Mutations at Baseline.
There were eight participants with no data at week 48: one LTFU, one protocol deviation (M184V at screening), two investigator decision (1 lung cancer, 1 M184V mutation detected in plasma RNA population genotyping at transient rebound, suppressed with dolutegravir/lamivudine not fulfilling criteria for virologic withdrawal), one consent withdrawal and three withdrawals for AEs. It was pre-specified to report all participants who discontinued with last available HIV-1 RNA ≥50 copies/mL in "Number of Participants with HIV-1 RNA ≥50 copies/mL" category at week 48.
Time frame: Week 48
Estimations of Virological Control
Proportion of VF (≥50 copies/mL) ITT-e, per protocol population (PP), Proportion of VF (≥200 copies/mL), ITT-e and PP population, FDA snapshot. Proportion of Confirmed Virologic Withdrawal (\[CVW\]: A VL≥ 50 copies/mL followed by a VL≥ 200 copies/mL in retest), ITT-e and PP population, FDA snapshot. Proportion of Precautionary Virologic Withdrawal (\[PVW\]: three consecutive VL between 50- 200 copies/mL), ITT-e and PP population, FDA snapshot. Proportion of participants with VL\<50 copies/mL, ITT-e and per protocol population, FDA snapshot.
Time frame: Week 48 and week 96
Viral Resistance in Persons Experiencing VF.
Percentage of VF with drug resistance associated mutations. \- Describe number and type of resistanceassociated mutations in VF
Time frame: Throughout all the study, an average of 96 weeks
Time to VF
Due to the low number of events, the analysis of factors associated with VF (i.e., time to VF) was not performed. Additionally, because of the limited number of events, analyses of NGS-related outcomes were conducted only at the 5% level. The pre-specified subgroup analyses were modified and replaced with analyses based on baseline 3TC or FTC use, confirmed prior resistance to 3TC, and prior exposure to INSTIs.
Time frame: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroups: Confirmed Historical M184V/I vs No Resistance Mutations
Time frame: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroups: INSTI Exposure vs No Prior INSTI Exposure
All participants with M184V/I detected at baseline in proviral DNA NGS had a VL \<50 copies/mL at week 48 or last study visit.
Time frame: Throughout all the study, an average of 96 weeks
Time Virologically Suppressed
Participants were virologically suppressed for 9 years before the study
Time frame: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroup: Time on 3TC/FTC
Time frame: Throughout all the study, an average of 96 weeks
Percentage of Participants With VF With Baseline 3TC or INSTI Resistanceassociated Mutations Detected at Baseline by NGS With 1, 5, and 20% Threshold.
Percentage of VF with drug resistance associated mutations and proportion of participants with VF with baseline 3TC or INSTI resistance- associated mutations detected at baseline by NGS with 5% threshold.
Time frame: Throughout all the study, an average of 96 weeks
Proportion of Participants With Transient Viral Rebounds With Baseline 3TC or INSTI Resistance- Associated Mutations Detected at Baseline by NGS With 1, 5, and 20% Threshold.
Proportion of participants with transient viral rebounds with baseline 3TC or INSTI resistance- associated mutations detected at baseline by NGS with 5% threshold.
Time frame: Throughout all the study, an average of 96 weeks
Number of Participants With M184V/I Presence by Successful Plasma RNA NGS in Participants With Virological Dropout
Next-generation sequencing (NGS) of plasma RNA was successful in one of the two virological withdrawal cases.
Time frame: Throughout all the study, an average of 96 weeks
Frequency of Resistance Mutations (RT and Integrase) in Proviral DNA Measured by NGS.
Time frame: Throughout all the study, an average of 96 weeks
Change in CD4+ Cell Count
CD4+ count values were observed throughout the 96 weeks.
Time frame: Basal, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72 and week 96
Change in CD4+/CD8+ Cell Counts Ratio
Time frame: Basal, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72 and week 96
Percentage and Severity of AEs and Laboratory Abnormalities.
Time frame: Basal, Week 48 and week 96
Proportion of Subjects Who Discontinue Treatment Due to AEs
Participants who discontinue treatment due to AEs (al week 96)
Time frame: Basal, week 48 and week 96
Sixteen participants discontinued by the following reasons: two virological withdrawals (1 Confirmed Virologic Withdrawal \[CVW\], 1 Precautionary Virologic Withdrawal \[PVW\]), four adverse-event withdrawals, two investigator decisions, two protocol violations, two consent withdrawals, three lost to follow-up and one unrelated death from Chronic Obstructive Pulmonary Disease (COPD) at week 96.
| Milestone | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Started | 167 |
| Itt-e (included all participants who received al least one dose of dtg/3t) | 121 |
| Per protocol population (pp) | 105 |
| Completed | 105 |
| Not completed | 62 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Adverse event | 4 |
| Withdrew: Physician decision | 2 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Death | 1 |
| Withdrew: Screening failure screening failure (participants who do not receive a dose of dtg/3tc) | 46 |
There were eight participants with no data at week 48: one LTFU, one protocol deviation (M184V at screening), two investigator decision (1 lung cancer, 1 M184V mutation detected in plasma RNA population genotyping at transient rebound, suppressed with dolutegravir/lamivudine not fulfilling criteria for virologic withdrawal), one consent withdrawal and three withdrawals for AEs. It was pre-specified to report all participants who discontinued with last available HIV-1 RNA ≥50 copies/mL in "Number of Participants with HIV-1 RNA ≥50 copies/mL" category at week 48.
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Number of Participants with HIV-1 RNA < 50 copies/mL | 109 |
| Number of Participants with HIV-1 RNA ≥50 copies/mL | 4 |
| Number of Participants with No virologic data at week 48 | 8 |
Proportion of VF (≥50 copies/mL) ITT-e, per protocol population (PP), Proportion of VF (≥200 copies/mL), ITT-e and PP population, FDA snapshot. Proportion of Confirmed Virologic Withdrawal (\[CVW\]: A VL≥ 50 copies/mL followed by a VL≥ 200 copies/mL in retest), ITT-e and PP population, FDA snapshot. Proportion of Precautionary Virologic Withdrawal (\[PVW\]: three consecutive VL between 50- 200 copies/mL), ITT-e and PP population, FDA snapshot. Proportion of participants with VL\<50 copies/mL, ITT-e and per protocol population, FDA snapshot.
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Percentage of VF (≥200 copies/mL) at week 48, ITT-e — Number of participants with VL <50/200 copies/mL | 109 |
| Percentage of VF (≥200 copies/mL) at week 48, ITT-e — Number of participants with VL >50/200 cop/ml: Lack of efficacy (CVW) | 1 |
| Percentage of VF (≥200 copies/mL) at week 48, ITT-e — Number of participants with VL >50/200 cop/ml: Lack of efficacy (PVW) | 0 |
| Percentage of VF (≥200 copies/mL) at week 48, ITT-e — Number of participants with VL >50/200 cop/ml: Discontinued for other reason VL≥50/200 | 1 |
| Percentage of VF (≥200 copies/mL) at week 48, ITT-e — Number of participants with No Data: Discontinued study due to AE or death | 4 |
| Percentage of VF (≥200 copies/mL) at week 48, ITT-e — Number of participants with No Data: Discontinued study for other reasons | 6 |
| Percentage of VF (≥200 copies/mL) at week 96, ITT-e — Number of participants with VL <50/200 copies/mL | 105 |
| Percentage of VF (≥200 copies/mL) at week 96, ITT-e — Number of participants with VL >50/200 cop/ml: Lack of efficacy (CVW) | 1 |
| Percentage of VF (≥200 copies/mL) at week 96, ITT-e — Number of participants with VL >50/200 cop/ml: Lack of efficacy (PVW) | 0 |
| Percentage of VF (≥200 copies/mL) at week 96, ITT-e — Number of participants with VL >50/200 cop/ml: Discontinued for other reason VL≥50/200 | 1 |
| Percentage of VF (≥200 copies/mL) at week 96, ITT-e — Number of participants with No Data: Discontinued study due to AE or death | 5 |
| Percentage of VF (≥200 copies/mL) at week 96, ITT-e — Number of participants with No Data: Discontinued study for other reasons | 9 |
| Percentage of VF (≥200 copies/mL) at week 48, PP — Number of participants with VL <50/200 copies/mL | 105 |
| Percentage of VF (≥200 copies/mL) at week 48, PP — Number of participants with VL >50/200 cop/ml: Lack of efficacy (CVW) | 0 |
| Percentage of VF (≥200 copies/mL) at week 48, PP — Number of participants with VL >50/200 cop/ml: Lack of efficacy (PVW) | 0 |
| Percentage of VF (≥200 copies/mL) at week 48, PP — Number of participants with VL >50/200 cop/ml: Discontinued for other reason VL≥50/200 | 0 |
| Percentage of VF (≥200 copies/mL) at week 48, PP — Number of participants with No Data: Discontinued study due to AE or death | 0 |
| Percentage of VF (≥200 copies/mL) at week 48, PP — Number of participants with No Data: Discontinued study for other reasons | 0 |
| Percentage of VF (≥200 copies/mL) at week 96, PP — Number of participants with VL <50/200 copies/mL | 105 |
| Percentage of VF (≥200 copies/mL) at week 96, PP — Number of participants with VL >50/200 cop/ml: Lack of efficacy (CVW) | 0 |
| Percentage of VF (≥200 copies/mL) at week 96, PP — Number of participants with VL >50/200 cop/ml: Lack of efficacy (PVW) | 0 |
| Percentage of VF (≥200 copies/mL) at week 96, PP — Number of participants with VL >50/200 cop/ml: Discontinued for other reason VL≥50/200 | 0 |
| Percentage of VF (≥200 copies/mL) at week 96, PP — Number of participants with No Data: Discontinued study due to AE or death | 0 |
| Percentage of VF (≥200 copies/mL) at week 96, PP — Number of participants with No Data: Discontinued study for other reasons | 0 |
| Percentage of VF (≥50 copies/mL) at week 96, ITT-e — Number of participants with VL <50/200 copies/mL | 105 |
| Percentage of VF (≥50 copies/mL) at week 96, ITT-e — Number of participants with VL >50/200 cop/ml: Lack of efficacy (CVW) | 1 |
| Percentage of VF (≥50 copies/mL) at week 96, ITT-e — Number of participants with VL >50/200 cop/ml: Lack of efficacy (PVW) | 1 |
| Percentage of VF (≥50 copies/mL) at week 96, ITT-e — Number of participants with VL >50/200 cop/ml: Discontinued for other reason VL≥50/200 | 2 |
| Percentage of VF (≥50 copies/mL) at week 96, ITT-e — Number of participants with No Data: Discontinued study due to AE or death | 4 |
| Percentage of VF (≥50 copies/mL) at week 96, ITT-e — Number of participants with No Data: Discontinued study for other reasons | 8 |
| Percentage of VF (≥50 copies/mL) at week 96, PP — Number of participants with VL <50/200 copies/mL | 105 |
| Percentage of VF (≥50 copies/mL) at week 96, PP — Number of participants with VL >50/200 cop/ml: Lack of efficacy (CVW) | 0 |
| Percentage of VF (≥50 copies/mL) at week 96, PP — Number of participants with VL >50/200 cop/ml: Lack of efficacy (PVW) | 0 |
| Percentage of VF (≥50 copies/mL) at week 96, PP — Number of participants with VL >50/200 cop/ml: Discontinued for other reason VL≥50/200 | 0 |
| Percentage of VF (≥50 copies/mL) at week 96, PP — Number of participants with No Data: Discontinued study due to AE or death | 0 |
| Percentage of VF (≥50 copies/mL) at week 96, PP — Number of participants with No Data: Discontinued study for other reasons | 0 |
Percentage of VF with drug resistance associated mutations. \- Describe number and type of resistanceassociated mutations in VF
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| No Mutations in DNA NGS — ≥50 c/mL | 1 |
| No Mutations in DNA NGS — <50 c/mL | 33 |
| No Mutations in DNA NGS — No virologic data | 1 |
| 184V/I in DNA NGS — ≥50 c/mL | 0 |
| 184V/I in DNA NGS — <50 c/mL | 21 |
| 184V/I in DNA NGS — No virologic data | 3 |
| Other mutations in DNA NGS — ≥50 c/mL | 3 |
| Other mutations in DNA NGS — <50 c/mL | 54 |
| Other mutations in DNA NGS — No virologic data | 4 |
Due to the low number of events, the analysis of factors associated with VF (i.e., time to VF) was not performed. Additionally, because of the limited number of events, analyses of NGS-related outcomes were conducted only at the 5% level. The pre-specified subgroup analyses were modified and replaced with analyses based on baseline 3TC or FTC use, confirmed prior resistance to 3TC, and prior exposure to INSTIs.
| years | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Time to VF | NA ± NA |
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Confirmed prior 3TC resistance — HIV-1 RNA >50 copies/mL at week 96 | 4 |
| Confirmed prior 3TC resistance — HIV-1 RNA <50 copies/mL at week 96 | 102 |
| Confirmed prior 3TC resistance — No data HIV-1 RNA | 8 |
| NO - Confirmed prior 3TC resistance — HIV-1 RNA >50 copies/mL at week 96 | 0 |
| NO - Confirmed prior 3TC resistance — HIV-1 RNA <50 copies/mL at week 96 | 7 |
| NO - Confirmed prior 3TC resistance — No data HIV-1 RNA | 0 |
All participants with M184V/I detected at baseline in proviral DNA NGS had a VL \<50 copies/mL at week 48 or last study visit.
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Number of participants with No Prior exposure to INSTIs — Number of participants with HIV-1 RNA >50 copies/mL at week 96 | 1 |
| Number of participants with No Prior exposure to INSTIs — Number of participants with HIV-1 RNA <50 copies/mL at week 96 | 52 |
| Number of participants with Prior exposure to INSTIs — Number of participants with HIV-1 RNA >50 copies/mL at week 96 | 3 |
| Number of participants with Prior exposure to INSTIs — Number of participants with HIV-1 RNA <50 copies/mL at week 96 | 65 |
Participants were virologically suppressed for 9 years before the study
| years | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Time Virologically Suppressed | NA (NA to NA) |
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Number of participants with No 3TC o FTC at baseline — Number of participants with HIV-1 RNA >50 copies/mL at week 96 | 2 |
| Number of participants with No 3TC o FTC at baseline — Number of participants with HIV-1 RNA <50 copies/mL at week 96 | 53 |
| Number of participants with 3TC o FTC at baseline — Number of participants with HIV-1 RNA >50 copies/mL at week 96 | 2 |
| Number of participants with 3TC o FTC at baseline — Number of participants with HIV-1 RNA <50 copies/mL at week 96 | 64 |
Percentage of VF with drug resistance associated mutations and proportion of participants with VF with baseline 3TC or INSTI resistance- associated mutations detected at baseline by NGS with 5% threshold.
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| No Mutations in DNA NGS — ≥50 c/mL | 1 |
| No Mutations in DNA NGS — <50 c/mL | 33 |
| No Mutations in DNA NGS — No virologic data | 1 |
| 184V/I in DNA NGS — ≥50 c/mL | 0 |
| 184V/I in DNA NGS — <50 c/mL | 21 |
| 184V/I in DNA NGS — No virologic data | 3 |
| Other mutations in DNA NGS — ≥50 c/mL | 3 |
| Other mutations in DNA NGS — <50 c/mL | 54 |
| Other mutations in DNA NGS — No virologic data | 4 |
Proportion of participants with transient viral rebounds with baseline 3TC or INSTI resistance- associated mutations detected at baseline by NGS with 5% threshold.
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Number of participants with the M184V/I detected at baseline through proviral DNA NGS | 4 |
| Number of participants without the M184V/I mutation at baseline through proviral DNA NGS | 16 |
Next-generation sequencing (NGS) of plasma RNA was successful in one of the two virological withdrawal cases.
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Number of Participants With M184V/I Presence by Successful Plasma RNA NGS in Participants With Virological Dropout | 1 |
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Number of participants without M184V/I at baseline and week 96 | 65 |
| Number of participants with M184V/I detected only at baseline | 12 |
| Number of participants with M184V/I detected only at week 96 | 13 |
| Number of participants with M184V/I detected at both | 12 |
| Number of participants with no data (amplification failure) | 3 |
CD4+ count values were observed throughout the 96 weeks.
| cell/mm3 | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| CD4+ Count change baseline | 706.96 ± 283.74 |
| CD4+ Count change week 4 | 739.83 ± 268.65 |
| CD4+ Count change week 12 | 715.60 ± 266.15 |
| CD4+ Count change week 24 | 742.77 ± 297.32 |
| CD4+ Count change week 36 | 726.15 ± 292.98 |
| CD4+ Count change week 48 | 706.13 ± 268.76 |
| CD4+ Count change week 72 | 769.30 ± 322.61 |
| CD4+ Count change week 96 | 716.44 ± 284.10 |
| ratio | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| CD4/CD8 Ratio Change Baseline | 1.06 ± 0.57 |
| CD4/CD8 Ratio Change Week 4 | 1.03 ± 0.56 |
| CD4/CD8 Ratio Change Week 12 | 1.03 ± 0.51 |
| CD4/CD8 Ratio Change Week 24 | 1.03 ± 0.55 |
| CD4/CD8 Ratio Change Week 36 | 1.00 ± 0.52 |
| CD4/CD8 Ratio Change Week 48 | 0.99 ± 0.50 |
| CD4/CD8 Ratio Change Week 72 | 1.03 ± 0.54 |
| CD4/CD8 Ratio Change Week 96 | 1.03 ± 0.58 |
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Any Adverse Event at week 96 — No | 10 |
| Any Adverse Event at week 96 — Yes | 111 |
| Adverse events grade 3-4 at week 96 — No | 109 |
| Adverse events grade 3-4 at week 96 — Yes | 12 |
| Serious Adverse Events at week 96 — No | 104 |
| Serious Adverse Events at week 96 — Yes | 17 |
| Adverse Events Drug-related at week 96 — No | 101 |
| Adverse Events Drug-related at week 96 — Yes | 20 |
| Drug-related Serious Adverse Events at week 96 — No | 120 |
| Drug-related Serious Adverse Events at week 96 — Yes | 1 |
| Drug-related Adverse Events grade 3-4 at week 96 — No | 119 |
| Drug-related Adverse Events grade 3-4 at week 96 — Yes | 2 |
| Adverse Events leading to withdrawal at week 96 — No | 117 |
| Adverse Events leading to withdrawal at week 96 — Yes | 4 |
| Adverse Events Death at week 96 — No | 120 |
| Adverse Events Death at week 96 — Yes | 1 |
| Cardiac disorders at week 96 — No | 120 |
| Cardiac disorders at week 96 — Yes | 1 |
| Gastrointestinal disorders at week 96 — No | 117 |
| Gastrointestinal disorders at week 96 — Yes | 4 |
| General disorders and administration site conditions at week 96 — No | 120 |
| General disorders and administration site conditions at week 96 — Yes | 1 |
| Infections and infestations at week 96 — No | 119 |
| Infections and infestations at week 96 — Yes | 2 |
| Investigations at week 96 — No | 120 |
| Investigations at week 96 — Yes | 1 |
| Metabolism and nutrition disorders at week 96 — No | 119 |
| Metabolism and nutrition disorders at week 96 — Yes | 2 |
| Nervous system disorders at week 96 — No | 114 |
| Nervous system disorders at week 96 — Yes | 7 |
| Psychiatric disorders at week 96 — No | 114 |
| Psychiatric disorders at week 96 — Yes | 7 |
| Renal and urinary disorders at week 96 — No | 120 |
| Renal and urinary disorders at week 96 — Yes | 1 |
| Surgical and medical procedures at week 96 — No | 120 |
| Surgical and medical procedures at week 96 — Yes | 1 |
| ALT. Laboratory Abnormalities 3/4 at week 96 — No | 120 |
| ALT. Laboratory Abnormalities 3/4 at week 96 — Yes | 1 |
| AST. Laboratory Abnormalities 3/4 at week 96 — No | 120 |
| AST. Laboratory Abnormalities 3/4 at week 96 — Yes | 1 |
| Cholesterol. Laboratory Abnormalities 3/4 at week 96 — No | 119 |
| Cholesterol. Laboratory Abnormalities 3/4 at week 96 — Yes | 2 |
| Triglycerides. Laboratory Abnormalities 3/4 at week 96 — No | 119 |
| Triglycerides. Laboratory Abnormalities 3/4 at week 96 — Yes | 2 |
| LDL. Laboratory Abnormalities 3/4 at week 96 — No | 117 |
| LDL. Laboratory Abnormalities 3/4 at week 96 — Yes | 4 |
| Alkaline phosphatas. Laboratory Abnormalities 3/4 at week 96 — No | 121 |
| Alkaline phosphatas. Laboratory Abnormalities 3/4 at week 96 — Yes | 0 |
| eGFR. Laboratory Abnormalities 3/4 at week 96 — No | 100 |
| eGFR. Laboratory Abnormalities 3/4 at week 96 — Yes | 21 |
| Any Adverse Event at week 48 — No | 27 |
| Any Adverse Event at week 48 — Yes | 94 |
| Adverse events grade 3-4 at week 48 — No | 113 |
| Adverse events grade 3-4 at week 48 — Yes | 8 |
| Serious Adverse Events at week 48 — No | 109 |
| Serious Adverse Events at week 48 — Yes | 12 |
| Adverse Events Drug-related at week 48 — No | 102 |
| Adverse Events Drug-related at week 48 — Yes | 19 |
| Drug-related Serious Adverse Events at week 48 — No | 120 |
| Drug-related Serious Adverse Events at week 48 — Yes | 1 |
| Drug-related Adverse Events grade 3-4 at week 48 — No | 119 |
| Drug-related Adverse Events grade 3-4 at week 48 — Yes | 2 |
| Adverse Events leading to withdrawal at week 48 — No | 117 |
| Adverse Events leading to withdrawal at week 48 — Yes | 4 |
| Adverse Events Death at week 48 — No | 121 |
| Adverse Events Death at week 48 — Yes | 0 |
| Cardiac disorders at week 48 — No | 120 |
| Cardiac disorders at week 48 — Yes | 1 |
| Gastrointestinal disorders at week 48 — No | 117 |
| Gastrointestinal disorders at week 48 — Yes | 4 |
| General disorders and administration site conditions at week 48 — No | 120 |
| General disorders and administration site conditions at week 48 — Yes | 1 |
| Infections and infestations at week 48 — No | 120 |
| Infections and infestations at week 48 — Yes | 1 |
| Investigations at week 48 — No | 120 |
| Investigations at week 48 — Yes | 1 |
| Metabolism and nutrition disorders at week 48 — No | 119 |
| Metabolism and nutrition disorders at week 48 — Yes | 2 |
| Nervous system disorders at week 48 — No | 114 |
| Nervous system disorders at week 48 — Yes | 7 |
| Psychiatric disorders at week 48 — No | 114 |
| Psychiatric disorders at week 48 — Yes | 7 |
| Renal and urinary disorders at week 48 — No | 120 |
| Renal and urinary disorders at week 48 — Yes | 1 |
| ALT. Laboratory Abnormalities 3/4 at week 48 — No | 120 |
| ALT. Laboratory Abnormalities 3/4 at week 48 — Yes | 1 |
| AST. Laboratory Abnormalities 3/4 at week 48 — No | 120 |
| AST. Laboratory Abnormalities 3/4 at week 48 — Yes | 1 |
| Choresterol. Laboratory Abnormalities 3/4 at week 48 — No | 119 |
| Choresterol. Laboratory Abnormalities 3/4 at week 48 — Yes | 2 |
| Triglycerides. Laboratory Abnormalities 3/4 at week 48 — No | 119 |
| Triglycerides. Laboratory Abnormalities 3/4 at week 48 — Yes | 2 |
| LDL. Laboratory Abnormalities 3/4 at week 48 — No | 118 |
| LDL. Laboratory Abnormalities 3/4 at week 48 — Yes | 3 |
| Alkaline phosphatas. Laboratory Abnormalities 3/4 at week 48 — No | 121 |
| Alkaline phosphatas. Laboratory Abnormalities 3/4 at week 48 — Yes | 0 |
| eGFR. Laboratory Abnormalities 3/4 at week 48 — No | 105 |
| eGFR. Laboratory Abnormalities 3/4 at week 48 — Yes | 16 |
Participants who discontinue treatment due to AEs (al week 96)
| Participants | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| participants who discontinue treatment due to AEs | 5 |
| participants who complete treatment | 116 |
Collected over From the signing of the ICF until the follow-up visit, an average of 96 weeks (100 weeks in case the participants with any ongoing adverse event or laboratory abnormality considered to be potentially harmful for the participant at week 96). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dovato (Dolutegravir+Lamivudine) | 1/167 (0.6%) | 17/167 (10.2%) | 65/167 (38.9%) |
| Event | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Proliferative cystitisRenal and urinary disorders | 1/167 |
| Nephritic colicRenal and urinary disorders | 1/167 |
| Fracture of the left oleacronMusculoskeletal and connective tissue disorders | 1/167 |
| Cutaneous AbscessSkin and subcutaneous tissue disorders | 1/167 |
| lung adenocarcinoma LSD and T4 N2 M1cNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/167 |
| DepressionPsychiatric disorders | 1/167 |
| Kidney stone surgerySurgical and medical procedures | 1/167 |
| Foreign body sigma impactionSurgical and medical procedures | 1/167 |
| Worsering of the condition Hyperplasia prostatic (as it is the cause of the surgery)Reproductive system and breast disorders | 1/167 |
| Inguinal Hernia RepairSurgical and medical procedures | 1/167 |
| Event | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| COVID19Infections and infestations | 20/167 |
| Respiratory infectionsInfections and infestations | 17/167 |
| HeadacheNervous system disorders | 10/167 |
| InsomniaPsychiatric disorders | 9/167 |
| LumbagoMusculoskeletal and connective tissue disorders | 9/167 |
| Age, Continuous(years) | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Median | 56.3 (51.9 to 59.8) |
| Sex: Female, Male(Participants) | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Female | 35 |
| Male | 86 |
| Race/Ethnicity, Customized(Participants) | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Caucasian | 102 |
| Latin | 18 |
| Afroamerican | 1 |
| Years since HIV diagnosis(years) | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Median | 26.2 (20.8 to 30.6) |
| Route of transmission(Participants) | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Men who have sex with men | 43 |
| Heterosexual sex | 36 |
| Intravenous drug use | 35 |
| Blood transfusion | 1 |
| Other/Unknown | 6 |
| Nadir CD4(cells/mm^3) | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Median | 180 (70 to 270) |
| Baseline CD4+ count(cells/mm3) | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Median | 706 (483 to 853) |
| ART duration(years) | Dovato (Dolutegravir+Lamivudine) |
|---|---|
| Median | 8 (6 to 12) |
13 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2021 to primary completion in Jun 2023, 22 months.
Results were first posted in Sep 2026, 3 years 2 months after primary completion.
Of 65 non-industry phase 2 interventional studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 74. This study's 22 months is below that.
Counting every sponsor, half of 99 studies reached it within 31 months; a quarter within 17 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dolutegravir · Dolutegravir Sodium/Lamivudine
Fundacion SEIMC-GESIDA