Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019

NCT03016533 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 205858
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 17

Brief 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. 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

Keywords

Dolutegravir; Continued access study; HIV-1; ABC/DTG/3TC; Pediatric

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Continued Access to Age Appropriate Formulation of Dolutegravir

  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)

  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

  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

  From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal

Study Arms (2)

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.

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.

Drug: ABC/DTG/3TC immediate release tablets; Drug: ABC/DTG/3TC film-coated dispersible tablets

Interventions

Dolutegravir film-coated tablets DRUG

Dolutegravir film-coated tablets will be provided as 50 mg tablets.

Dolutegravir (DTG)

Dolutegravir film-coated dispersible tablets DRUG

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.

Dolutegravir (DTG)

ABC/DTG/3TC immediate release tablets DRUG

ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC.

Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC)

ABC/DTG/3TC film-coated dispersible tablets DRUG

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.

Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC)

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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);
• 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).
• 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.

You may not qualify if:

• 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.
• Previous permanent discontinuation from investigational product in the parent study due to toxicity, intolerance or pregnancy.
• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (17)

GSK Investigational Site

Los Angeles, California, 90095, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38105-3678, United States

Location

GSK Investigational Site

Gaborone, Botswana

Location

GSK Investigational Site

Belo Horizonte, 30130-100, Brazil

Location

GSK Investigational Site

Nova Iguaçu, 26030-380, Brazil

Location

GSK Investigational Site

RibeirAo PretoSP, 14048-900, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 21941-612, Brazil

Location

GSK Investigational Site

Cape Town, 7505, South Africa

Location

GSK Investigational Site

Johannesburg, 2001, South Africa

Location

GSK Investigational Site

Soweto, 1862, South Africa

Location

GSK Investigational Site

Umlazi, 4066, South Africa

Location

GSK Investigational Site

Moshi, 3010, Tanzania

Location

GSK Investigational Site

Bangkok, 10700, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

GSK Investigational Site

Chiang Rai, 57000, Thailand

Location

GSK Investigational Site

Harare, Zimbabwe

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: June 6, 2017
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (3); TA (1); TH (3); ZA (4); ZI (1); BO (1); BR (4)