A Phase 3 interventional study of Dolutegravir film-coated tablets and Dolutegravir film-coated dispersible tablets in HIV Infections, sponsored by ViiV Healthcare. Completed at 17 sites in 7 countries. Open to participants aged Up to 25 Years. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment
Among 55 studies testing dolutegravir in HIV Infections — 7 open to participants now, 9 under way, 4 of them phase 3. Dolutegravir · HIV Infections.
Among the 55 studies testing dolutegravir in HIV Infections, this one is the 34th largest by enrollment, is one of 3 that started in 2017, is one of 21 in phase 3, and was the 26th registered.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →7 of the 55 studies testing dolutegravir in HIV Infections are open now, in 12 countries. Each count lists the studies.
Dolutegravir: first FDA approval 2013 (TIVICAY), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: Up to 25 Years · all sexes · no healthy volunteers.
The full table on the hub →55 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2017.
Median enrollment 126 across the 55 interventional studies. Of the 43 that completed or were terminated, 26 (60%) have results posted.
28 of 55 have an industry lead sponsor. The 10 most frequent:
ViiV Healthcare is the lead sponsor of 265 studies on the registry; 16 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
154 studies in HIV Infections by ViiV Healthcare: 14 open now, 26 under way, 8 of them phase 3. Of 127 finished, 86 (68%) have results posted.
Among the 154 studies in HIV Infections by ViiV Healthcare, this one is the 62nd largest by enrollment of the 143 interventional ones, is one of 7 that started in 2017, is one of 37 in phase 3, and was the 68th registered.
ViiV Healthcare’s HIV Infections studies by the year they started, since 2002.
1 of the studies testing dolutegravir in HIV Infections that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07031063Instituto Mexicano del Seguro SocialSafety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience | 2026-12-01 |
Among the 55 studies testing dolutegravir in HIV Infections, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among ViiV Healthcare’s 154 in HIV Infections:
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir. This is a phase 3b, non-randomized, open-label, multi-center, two treatment rollover study. The primary objective of this pediatric interventional study is to provide continued access to age appropriate formulations of investigational product (dolutegravir), either as Tivicay or as part of fixed dose combination ABC/DTG/3TC, for eligible participants who previously participated in parent studies P1093 (NCT01302847) or P2019 (NCT03760458) and who cannot locally access age appropriate formulations of dolutegravir or ABC/DTG/3TC in the public sector. The P1093 study was designed to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral activity of dolutegravir in combination with optimized background regimens in human immunodeficiency virus type 1 (HIV-1) experienced adolescents and children as well as treatment naïve infants and toddlers. The P2019 study was designed to evaluate PK, safety, tolerability and antiviral activity of ABC/DTG/3TC dispersible and immediate release tablets in HIV-1-infected children. Participants who have tolerated investigational product in the parent studies without any significant toxicity or signs of virologic failure leading to the permanent discontinuation of investigational product and withdrawal from the parent study will be considered for this open label continued access study. Participants will receive their age/weight appropriate dose of investigational product as defined in the parent study. The duration of participation in the study will extend until age appropriate formulations of Tivicay or ABC/DTG/3TC receive local (by country) regulatory approval and are available in those countries from another source (e.g. government programs, aid programs, assistance programs, etc.) or the participant is no longer deriving benefit from treatment or meets a protocol defined reason for discontinuation. Participants will be enrolled after all screening procedures have been completed. In most cases, the Screening visit will overlap with the participants penultimate visit on the parent study (at Week 180 of P1093, or Week 36 of the P2019 study). Participants who meet all entry criteria may enroll and will be seen in the clinic every 12 weeks for a safety evaluation and to receive investigational product. It is estimated that no more than 300 participants will be enrolled in this study. Tivicay is a registered trademark of ViiV Healthcare.
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.
Participant must have completed participation in one of the following parent studies, for the duration noted, with continued benefit from product:
Virological control:
Evidence of continued benefit from IP during the subject's participation in the parent study (P1093 or P2019)
Exclusion Criteria:
Confirmed virologic failure with evidence of resistance to:
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
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 score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
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.
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.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.
Drug: Dolutegravir film-coated tablets · Drug: Dolutegravir film-coated dispersible tablets
Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.
Drug: ABC/DTG/3TC immediate release tablets · Drug: ABC/DTG/3TC film-coated dispersible tablets
Dolutegravir film-coated tablets will be provided as 50 mg tablets.
Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band.
ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC.
ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC.
Number of Participants With Continued Access to Age Appropriate Formulation of Dolutegravir
Time frame: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Number of Participants With Any Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade or relationship to the study interventions.
Time frame: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Number of Participants With SAEs Leading to Discontinuation of Study Treatment
Time frame: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Number of Participants With Any Clinical or Laboratory Adverse Events (AEs) Leading to Discontinuation of Study Treatment
Time frame: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Participants who completed one of the parent studies, either P1093 (NCT01302847) or P2019 (NCT03760458), were enrolled in this rollover study. Participants entered and were evaluated in the study at various study sites beginning June 2017 through December 2024.
| Milestone | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) |
|---|---|---|
| Started | 61 | 39 |
| Completed | 53 | 29 |
| Not completed | 8 | 10 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Physician decision | 5 | 10 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Participants | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) |
|---|---|---|
| Number of Participants With Continued Access to Age Appropriate Formulation of Dolutegravir | 53 | 29 |
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade or relationship to the study interventions.
| Participants | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) |
|---|---|---|
| Number of Participants With Any Serious Adverse Events (SAEs) | 5 | 3 |
| Participants | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) |
|---|---|---|
| Number of Participants With SAEs Leading to Discontinuation of Study Treatment | 0 | 0 |
| Participants | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) |
|---|---|---|
| Number of Participants With Any Clinical or Laboratory Adverse Events (AEs) Leading to Discontinuation of Study Treatment | 0 | 0 |
Collected over SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dolutegravir (DTG) | 0/61 (0%) | 5/61 (8.2%) | 0/61 (0%) |
| Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) | 0/39 (0%) | 3/39 (7.7%) | 0/39 (0%) |
| Event | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) |
|---|---|---|
| COVID-19Infections and infestations | 1/61 | 1/39 |
| Dengue feverInfections and infestations | 0/61 | 1/39 |
| GastroenteritisInfections and infestations | 0/61 | 1/39 |
| Anaemia megaloblasticBlood and lymphatic system disorders | 1/61 | 0/39 |
| HaemoperitoneumGastrointestinal disorders | 1/61 | 0/39 |
| EpididymitisInfections and infestations | 1/61 | 0/39 |
| Petit mal epilepsyNervous system disorders | 1/61 | 0/39 |
| Age, Continuous(YEARS) | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) | Total |
|---|---|---|---|
| Mean | 7.5 ± 4.07 | 6.7 ± 3.14 | 7.2 ± 3.74 |
| Sex: Female, Male(Participants) | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) | Total |
|---|---|---|---|
| Female | 32 | 17 | 49 |
| Male | 29 | 22 | 51 |
| Race/Ethnicity, Customized(Participants) | Dolutegravir (DTG) | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) | Total |
|---|---|---|---|
| ASIAN | 11 | 15 | 26 |
| BLACK OR AFRICAN AMERICAN | 47 | 23 | 70 |
| WHITE | 3 | 1 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Study sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · www.viiv-studyregister.com
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dolutegravir