HIV InfectionsPhase 3NCT03016533
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
A Phase 3 study testing Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets and ABC/DTG/3TC immediate release tablets in people with HIV Infections, run by ViiV Healthcare at 17 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets and ABC/DTG/3TC immediate release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 6 Jun 2017to 24 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant must have completed participation in one of the following parent studies, for the duration noted, with continued benefit from investigational product:
- P1093 parent study through at least Week 180;
- P2019 parent study through at least Week 48.
- Participant with evidence of Virological Failure in either parent study must have eligibility for this rollover study discussed and agreed with the ViiV Healthcare Medical Monitor.
- Virological control:
- Participants in parent study P1093 must have virological control defined as HIV-1 ribonucleic acid (RNA) <400 copies per milliliter (c/mL) at their penultimate visit (on or after the Week 180 visit);
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- Participants in parent study P2019 must have virological control defined as HIV-1 RNA <200 c/mL at their penultimate visit (on or after Week 36).
- Evidence of continued benefit from IP during the subject's participation in the parent study (P1093 or P2019)
- At screening, Investigators will submit a clinical summary verifying evidence of continued benefit from IP during the subject's participation in the parent study (P1093 or P2019).
- The summary will be submitted via the PPD ePIP system to the Study Medical Monitor who will review and confirm if the inclusion criterion has been met.
- Confirmation from the Study Medical Monitor is required to meet this eligibility criterion
- Males and Females: All participants who are engaging in sexual activity should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (example [e.g.] male condom) and on the risk of HIV transmission to an uninfected partner. Females: Female participants who are of child- bearing potential and who are engaging in sexual activity that could lead to pregnancy, must agree to use one of the acceptable birth control methods until the last dose of study medication and completion of the follow-up visit (4 weeks after the last dose). Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
- Parent or legal guardian or participant >=18 years of age is able and willing to provide signed informed consent.
Who cannot join
- Confirmed virologic failure with evidence of resistance to:
- DTG in the P1093 parent study, or
- ABC, DTG or 3TC (with the exception of M184V) in the P2019 parent study
- Presence of any active AIDS defining opportunistic infection.
- Known >=grade 3 laboratory toxicities prior to study entry (e.g. neutrophil count, hemoglobin, platelets, aspartate aminotransferase [AST], alanine aminotransferase [ALT], lipase, serum creatinine and total bilirubin) would be considered exclusionary if identified at or after the penultimate parent study visit, prior to enrollment in the study... Repeat testing is allowed for eligibility determination.
- Previous permanent discontinuation from investigational product in the parent study due to toxicity, intolerance or pregnancy.
Show all 17Show fewer
- Known ALT >=5 times the upper limit of normal (ULN), or ALT >=3 times ULN and bilirubin >=1.5 times ULN (with >35 percent [%] direct bilirubin) would be considered exclusionary if identified at or after the penultimate parent study visit, prior to enrolment in the study.. Participants with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification should be excluded.
- Participants positive for hepatitis B virus at any time prior to entry (hepatitis B virus surface antigen positive).
- Females who are pregnant or plan to become pregnant or breastfeed during the study.
- Participant is currently participating in or has participated in a study with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from the sponsor's medical monitor is granted.
- Presence of any history of allergy/sensitivity to any of the study drugs.
- Participants transitioning from the P2019 study (taking ABC/DTG/3TC) have evidence of being Human Leukocyte Antigen-B*5701- positive based on documented testing at any time prior to entry.
- Use of any disallowed medications at time of Screening.
- Anticipated need for Hepatitis C virus therapy with interferon or any drugs that have potential for adverse drug: drug interactions with study treatment throughout the entire study period.
- Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Clinical or symptomatic evidence of pancreatitis, as determined by the clinician.
- Any condition (including but not limited to alcohol and drug use) that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
Brazil4 sites
GSK Investigational Site
Belo Horizonte, 30130-100
GSK Investigational Site
Nova Iguaçu, 26030-380
GSK Investigational Site
RibeirAo PretoSP, 14048-900
GSK Investigational Site
Rio de Janeiro, 21941-612
South Africa4 sites
GSK Investigational Site
Cape Town, 7505
GSK Investigational Site
Johannesburg, 2001
GSK Investigational Site
Soweto, 1862
GSK Investigational Site
Umlazi, 4066
United States3 sites
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Los Angeles, California, 90095
GSK Investigational Site
Memphis, Tennessee, 38105-3678
Thailand3 sites
GSK Investigational Site
Bangkok, 10700
GSK Investigational Site
Chiang Mai, 50200
GSK Investigational Site
Chiang Rai, 57000
About this study
Official title: Open-label Access to Dolutegravir for HIV-1 Infected Children and Adolescents Completing IMPAACT Studies P1093 and P2019
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.
- Conditions
- HIV Infections
- Being tested
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets, ABC/DTG/3TC film-coated dispersible tablets
- Keywords
- Dolutegravir, Continued access study, HIV-1, ABC/DTG/3TC, Pediatric
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir film-coated tabletsDrug
Dolutegravir film-coated tablets will be provided as 50 mg tablets.
Dolutegravir film-coated dispersible tabletsDrug
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 tabletsDrug
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 film-coated dispersible tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir (DTG) | Experimental | 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. Receives: Drug: Dolutegravir film-coated tablets; Drug: Dolutegravir film-coated dispersible tablets |
| Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) | Experimental | 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. Receives: Drug: ABC/DTG/3TC immediate release tablets; Drug: ABC/DTG/3TC film-coated dispersible tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Continued Access to Age Appropriate Formulation of Dolutegravir
Measured: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start6 Jun 2017
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016533
- Sponsor's protocol ID
- 205858
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2017
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Access to Dolutegravir for HIV-1 Infected Children and Adolescents Completing IMPAACT Studies P1093 and P2019
- ClinicalTrials.gov ID
- NCT03016533
- Acronym / sponsor ID
- 205858
- Conditions
- HIV Infections
- Keywords
- Dolutegravir, Continued access study, HIV-1, ABC/DTG/3TC, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir (DTG) | Experimental | Drug: Dolutegravir film-coated tablets, Drug: Dolutegravir film-coated dispersible tabletsParticipants 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. |
| Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) | Experimental | Drug: ABC/DTG/3TC immediate release tablets, Drug: ABC/DTG/3TC film-coated dispersible tabletsParticipants 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. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Participant must have completed participation in one of the following parent studies, for the duration noted, with continued benefit from investigational product:
- Participant with evidence of Virological Failure in either parent study must have eligibility for this rollover study discussed and agreed with the ViiV Healthcare Medical Monitor.
- Virological control:
- Evidence of continued benefit from IP during the subject's participation in the parent study (P1093 or P2019)
- Males and Females: All participants who are engaging in sexual activity should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (example [e.g.] male condom) and on the risk of HIV transmission to an uninfected partner. Females: Female participants who are of child- bearing potential and who are engaging in sexual activity that could lead to pregnancy, must agree to use one of the acceptable birth control methods until the last dose of study medication and completion of the follow-up visit (4 weeks after the last dose). Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
Key exclusion criteria (17 listed)
- Confirmed virologic failure with evidence of resistance to:
- Presence of any active AIDS defining opportunistic infection.
- Known >=grade 3 laboratory toxicities prior to study entry (e.g. neutrophil count, hemoglobin, platelets, aspartate aminotransferase [AST], alanine aminotransferase [ALT], lipase, serum creatinine and total bilirubin) would be considered exclusionary if identified at or after the penultimate parent study visit, prior to enrollment in the study... Repeat testing is allowed for eligibility determination.
- Previous permanent discontinuation from investigational product in the parent study due to toxicity, intolerance or pregnancy.
- Known ALT >=5 times the upper limit of normal (ULN), or ALT >=3 times ULN and bilirubin >=1.5 times ULN (with >35 percent [%] direct bilirubin) would be considered exclusionary if identified at or after the penultimate parent study visit, prior to enrolment in the study.. Participants with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification should be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolutegravir film-coated tabletsDolutegravir film-coated tablets will be provided as 50 mg tablets. | Drug | Dolutegravir (DTG) |
| Dolutegravir film-coated dispersible tabletsDolutegravir 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. | Drug | Dolutegravir (DTG) |
| ABC/DTG/3TC immediate release tabletsABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC. | Drug | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) |
| ABC/DTG/3TC film-coated dispersible tabletsABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC. | Drug | Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) |
Primary outcome
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
3 secondary outcomes
Number of Participants With Any Serious Adverse Events (SAEs)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets and ABC/DTG/3TC immediate release tablets in people with HIV Infections, run by ViiV Healthcare at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Brazil, South Africa, United States, Thailand, Botswana and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.