A Phase 4 interventional study of Dolutegravir 50 mg in Infection, Human Immunodeficiency Virus and HIV Infections, sponsored by ViiV Healthcare. Completed at 11 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 4, Interventional, and Treatment
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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 42nd largest by enrollment, is one of 7 that started in 2016, is one of 11 in phase 4, and was the 28th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →7 of the 55 studies testing dolutegravir in HIV Infections are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in Romania, South Africa, Uganda
José Antonio Mata Marín · Sites in Mexico
Ages 18–70
Instituto Mexicano del Seguro Social · Sites in Mexico
Ages 18+
José Antonio Mata Marín · Sites in Mexico
Ages 18–70 · Men only
ViiV Healthcare · Sites in United States
Ages 6–12
By country, each count listing its 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 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 15 · Phase 3 24 · Phase 4 11
First in 2009; this study’s year is marked. 7 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 43 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 126 across the 55 interventional studies. Of the 43 that completed or were terminated, 26 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
28 of 55 have an industry lead sponsor. The 10 most frequent:
This study is registered under ViiV Healthcare, one of the names counted as GlaxoSmithKline. Under that name alone:
ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
265 studies in HIV Infections by GlaxoSmithKline: 14 open now, 26 under way, 8 of them phase 3. Of 230 finished, 95 (41%) have results posted.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 140th largest by enrollment of the 209 interventional ones that give a count, is one of 8 that started in 2016, is one of 18 in phase 4, and was the 183rd registered.
GlaxoSmithKline’s HIV Infections studies by the year they started, since 1994.
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 |
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Among the 55 studies testing dolutegravir in HIV Infections, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 265 in HIV Infections:
This tab as a report to print or save as PDF → With an account.
DTG 50 milligram (mg) tablet was approved for marketing in Russian Federation; however, DTG is not currently available for subjects at Acquired Immune Deficiency Syndrome (AIDS) Centers as it is not available for order and supply via Federal program. This study is an open-label study which will include subjects, who complete taking DTG in studies ING112276, ING113086, ING114915, ING111762, and those subjects who end participation in study 200304 in which they received either DTG or lopinavir/ritonavir (LPV/RTV). DTG will be supplied at a dose of 50 mg once daily to eligible subjects until the subject stops taking DTG or transitions to commercial supply of DTG when available at AIDS Centers via the Federal program. The objective of this study is to bridge the gap between the closure of ING112276, ING113086, ING114915, ING111762 or end of subject's participation in 200304 and the actual availability of commercial DTG at AIDS Centers via Federal program for human immunodeficiency (HIV)-1-infected adult subjects in Russian Federation. The study will also investigate long-term safety of DTG for subjects continuing DTG in Russian Federation.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
Compared within HIV Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
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.
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.
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.
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.
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.
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.
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.
HIV positive subjects who complete taking DTG in studies ING112276, ING113086, ING114915, ING111762 and those subjects who end participation in study 200304 in which they received either DTG or LPV/RTV will be included in this study.
Drug: Dolutegravir 50 mg
DTG is an integrase inhibitor that has been developed for ART of HIV-infection in combination with other antiretrovirals. DTG will be available as 50 mg tablets to be administered once daily.
Number of subjects with drug related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Drug related AE is defined as all untoward and unintended responses to an investigational medicinal product related to any dose administered. All AEs will be graded according to Division of AIDS (DAIDS) toxicity scale.
Time frame: Up to 7 months approximately
Number of subjects with abnormal hematology parameters
Hematology parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Time frame: Up to 7 months approximately
Number of subjects with abnormal clinical chemistry parameters
Clinical chemistry parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Time frame: Up to 7 months approximately
Number of subjects with abnormal urine parameters
Urine parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Time frame: Up to 7 months approximately
Number of subjects with abnormal electrocardiogram (ECG)
The number of subjects with abnormal ECG results will be summarized.
Time frame: Up to 7 months approximately
Number of subjects with abnormal radiological scan
The number of subjects with abnormal radiological scan will be summarized.
Time frame: Up to 7 months approximately
Number of subjects with abnormal physical examination
The number of subjects with abnormal physical examination will be summarized
Time frame: Up to 7 months approximately
Number of subjects with abnormal blood pressure
The number of subjects with abnormal blood pressure will be summarized.
Time frame: Up to 7 months approximately
Number of subjects with abnormal heart rate
The number of subjects with abnormal heart rate will be summarized.
Time frame: Up to 7 months approximately
Number of subjects with abnormal temperature
The number of subjects with abnormal body temperature will be summarized.
Time frame: Up to 7 months approximately
Number of subjects with abnormal respiratory rate
The number of subjects with abnormal respiratory rate will be summarized.
Time frame: Up to 7 months approximately
Number of subjects receiving concomitant medications
All the concomitant medications that the subject will receive will be evaluated.
Time frame: Up to 7 months approximately
Number of subjects achieving HIV-1 ribonucleic acid (RNA) suppression < 50 copies per milliliter (c/mL)
Efficacy of DTG will be assessed at routine clinical practice based on the maintenance of HIV-1 RNA suppression at \<50 c/mL.
Time frame: Up to 7 months approximately
Ran from Dec 2016 to primary completion in Oct 2018, 21 months.
Of 91 phase 4 interventional studies under HIV Infections, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 44. This study's 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dolutegravir