Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
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ClinicalTrials.gov Identifier: NCT03016533 |
Recruitment Status :
Recruiting
First Posted : January 10, 2017
Last Update Posted : January 31, 2022
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections | Drug: Dolutegravir film-coated tablets Drug: Dolutegravir film-coated dispersible tablets Drug: ABC/DTG/3TC immediate release tablets Drug: ABC/DTG/3TC film-coated dispersible tablets | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label Access to Dolutegravir for HIV-1 Infected Children and Adolescents Completing IMPAACT Studies P1093 and P2019 |
Actual Study Start Date : | June 7, 2017 |
Estimated Primary Completion Date : | September 30, 2024 |
Estimated Study Completion Date : | September 30, 2024 |
Arm | Intervention/treatment |
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Experimental: Dolutegravir (Tivicay)
All participants will receive dolutegravir film-coated tablets or film-coated dispersible tablets at appropriate doses selected as per their age and weight bands. For those participants who were previously receiving dolutegravir in study P1093 (parent study), dolutegravir will be supplied as film-coated tablets containing 10 milligram (mg), 25 mg and 50 mg; and 5 mg film-coated dispersible tablets of dolutegravir. Participants will receive dolutegravir until age-appropriate formulations are available to them from some other source, or until participant is no longer deriving benefit from treatment, or participant is discontinued, or until development of dolutegravir is terminated. The dose adjustment will be made if a participant's weight change requires a dose adjustment.
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Drug: Dolutegravir film-coated tablets
Dolutegravir film-coated tablets will be provided as 10 mg, 25 mg and 50 mg tablets. It will be administered at the dose of approximately 1 mg/kilogram (kg) with maximum dose of 50 mg to participants as per their age and weight band. Drug: Dolutegravir film-coated dispersible 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. |
Experimental: ABC/DTG/3TC
All participants will receive ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets at appropriate doses selected as per their weight bands. For those participants who were previously receiving ABC/DTG/3TC in study P2019 (parent study), ABC/DTG/3TC will be supplied as immediate release tablets containing 600 mg, 50 mg and 300 mg of ABC, DTG, and 3TC respectively and film-coated dispersible tablets containing 60 mg, 5 mg and 30 mg of ABC, DTG, and 3TC respectively. Participants will receive ABC/DTG/3TC until age-appropriate formulations are available to them from some other source, until participant is no longer deriving benefit from treatment, or until participant is discontinued, or until development of ABC/DTG/3TC is terminated. The dose adjustment will be made if a participant's weight change requires a dose adjustment.
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Drug: ABC/DTG/3TC immediate release tablets
ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC. Drug: ABC/DTG/3TC film-coated dispersible tablets 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: Up to 4 years ]To provide access to age appropriate formulation of investigational product (dolutegravir), either as Tivicay or as fixed dose combination ABC/DTG/3TC in an open-label protocol to eligible participants who have completed P1093 and P2019 studies respectively.
- Number of participants with serious adverse events (SAEs) as a measure of safety [ Time Frame: Up to 2 years ]An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function.
- Number of participants with SAEs based on the severity [ Time Frame: Up to 2 years ]An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. The Division of acquired immunodeficiency syndrome (DAIDS) table for grading the severity of adult and pediatric adverse events will be used to assess severity.
- Number of participants with any clinical or laboratory adverse events leading to discontinuation of investigational product [ Time Frame: Up to 2 years ]An adverse event is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the investigational product.

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Ages Eligible for Study: | up to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant must have completed participation in one of the following parent studies, for the duration noted, with continued benefit from investigational product: a. P1093 parent study through at least Week 180; b. 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: a. 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); b. 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).
- 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.
Exclusion Criteria:
- 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). Repeat testing is allowed for eligibility determination.
- Previous permanent discontinuation from investigational product in the parent study due to toxicity, intolerance or pregnancy.
- 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) within 30 days prior to study entry. Participants with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification should be excluded.
- Estimated glomerular filtration rate (eGFR) bedside Schwartz formula; <60 milliliter per minute per 1.73 square meter within 30 days prior to study entry.
- Participants positive for hepatitis B virus in the parent study (hepatitis B virus surface antigen positive).
- Female 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) must be Human Leukocyte Antigen-B*5701-negative 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016533
Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
United States, California | |
GSK Investigational Site | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jaime G DeVille | |
United States, Florida | |
GSK Investigational Site | Recruiting |
Fort Lauderdale, Florida, United States, 33316 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Lisa Gay Robinson | |
United States, Tennessee | |
GSK Investigational Site | Recruiting |
Memphis, Tennessee, United States, 38105-3678 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Patricia Flynn | |
Botswana | |
GSK Investigational Site | Recruiting |
Gaborone, Botswana | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Gaerolwe R Masheto | |
Brazil | |
GSK Investigational Site | Recruiting |
Belo Horizonte, Minas Gerais, Brazil, 30130-100 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jorge Andrade Pinto | |
GSK Investigational Site | Recruiting |
Rio de Janeiro, Brazil, 21941-612 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Ricardo Hugo Oliveira | |
GSK Investigational Site | Recruiting |
Rio de Janeiro, Brazil, 26030-380 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jose Henrique de Silva Pilotto | |
South Africa | |
GSK Investigational Site | Recruiting |
Hillbrow, Gauteng, South Africa, 2001 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Lee Fairlie | |
GSK Investigational Site | Recruiting |
Cape Town, South Africa, 7505 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Mark Cotton | |
GSK Investigational Site | Recruiting |
Soweto, South Africa, 1862 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Afaaf Liberty | |
GSK Investigational Site | Recruiting |
Umlazi, South Africa, 4066 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Moherndran Archary | |
Tanzania | |
GSK Investigational Site | Recruiting |
Moshi, Tanzania, 3010 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Blandina MMbaga | |
Thailand | |
GSK Investigational Site | Recruiting |
Bangkok, Thailand, 10700 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Kulkanya Chokephaibulkit | |
GSK Investigational Site | Recruiting |
Chiang Mai, Thailand, 50200 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Virat Sirisanthana | |
GSK Investigational Site | Recruiting |
Chiangrai, Thailand, 57000 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Pradthana Ounchanum | |
Zimbabwe | |
GSK Investigational Site | Recruiting |
Harare, Zimbabwe | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Mutsawashe Bwakura-Dangarembizi |
Study Director: | GSK Clinical Trials | ViiV Healthcare |
Responsible Party: | ViiV Healthcare |
ClinicalTrials.gov Identifier: | NCT03016533 |
Other Study ID Numbers: |
205858 |
First Posted: | January 10, 2017 Key Record Dates |
Last Update Posted: | January 31, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD for this study will be made available via the Clinical Study Data Request site. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
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. |
URL: | http://clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dolutegravir Continued access study HIV-1 ABC/DTG/3TC Pediatric |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Lamivudine Dolutegravir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents HIV Integrase Inhibitors Integrase Inhibitors |