Phase
Condition
Hiv Infections
Treatment
Dolutegravir film-coated dispersible tablets
Dolutegravir film-coated tablets
ABC/DTG/3TC immediate release tablets
Clinical Study ID
Ages < 25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant must have completed participation in one of the following parentstudies, for the duration noted, with continued benefit from investigationalproduct:
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 haveeligibility for this rollover study discussed and agreed with the ViiV HealthcareMedical Monitor.
Virological control:
Participants in parent study P1093 must have virological control defined asHIV-1 ribonucleic acid (RNA) <400 copies per milliliter (c/mL) at theirpenultimate visit (on or after the Week 180 visit);
Participants in parent study P2019 must have virological control defined asHIV-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 theparent study (P1093 or P2019)
At screening, Investigators will submit a clinical summary verifying evidenceof continued benefit from IP during the subject's participation in the parentstudy (P1093 or P2019).
The summary will be submitted via the PPD ePIP system to the Study MedicalMonitor who will review and confirm if the inclusion criterion has been met.
Confirmation from the Study Medical Monitor is required to meet thiseligibility criterion
Males and Females: All participants who are engaging in sexual activity should becounseled on safer sexual practices including the use and benefit/risk of effectivebarrier methods (example [e.g.] male condom) and on the risk of HIV transmission toan uninfected partner. Females: Female participants who are of child- bearingpotential and who are engaging in sexual activity that could lead to pregnancy, mustagree to use one of the acceptable birth control methods until the last dose ofstudy medication and completion of the follow-up visit (4 weeks after the lastdose). Condoms are recommended in addition, because their appropriate use is theonly contraception method effective for preventing HIV-1 transmission.
Parent or legal guardian or participant >=18 years of age is able and willing toprovide signed informed consent.
Exclusion
Exclusion Criteria:
- 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 consideredexclusionary if identified at or after the penultimate parent study visit, prior toenrollment in the study... Repeat testing is allowed for eligibility determination.
Previous permanent discontinuation from investigational product in the parent studydue to toxicity, intolerance or pregnancy.
Known ALT >=5 times the upper limit of normal (ULN), or ALT >=3 times ULN andbilirubin >=1.5 times ULN (with >35 percent [%] direct bilirubin) would beconsidered exclusionary if identified at or after the penultimate parent studyvisit, prior to enrolment in the study.. Participants with moderate to severehepatic impairment (Class B or greater) as determined by Child-Pugh classificationshould be excluded.
Participants positive for hepatitis B virus at any time prior to entry (hepatitis Bvirus 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 acompound or device that is not commercially available within 30 days of signinginformed 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 evidenceof being Human Leukocyte Antigen-B*5701- positive based on documented testing at anytime prior to entry.
Use of any disallowed medications at time of Screening.
Anticipated need for Hepatitis C virus therapy with interferon or any drugs thathave potential for adverse drug: drug interactions with study treatment throughoutthe entire study period.
Participant is unlikely to adhere to the study procedures, keep appointments, or isplanning 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 theopinion of the site investigator, place the participant at an unacceptable risk ofinjury or render the participant unable to meet the requirements of the protocol.
Study Design
Connect with a study center
GSK Investigational Site
Gaborone,
BotswanaSite Not Available
GSK Investigational Site
Nova Iguacu, Rio De Janeiro 26030-380
BrazilSite Not Available
GSK Investigational Site
Ribeirao Preto, São Paulo 14048-900
BrazilSite Not Available
GSK Investigational Site
Belo Horizonte, 30130-100
BrazilSite Not Available
GSK Investigational Site
Nova IguaCu, 26030-380
BrazilSite Not Available
GSK Investigational Site
RibeirAo PretoSP, 14048-900
BrazilSite Not Available
GSK Investigational Site
Rio de Janeiro, 21941-612
BrazilSite Not Available
GSK Investigational Site
Hillbrow, Gauteng 2001
South AfricaSite Not Available
GSK Investigational Site
Cape Town, 7505
South AfricaSite Not Available
GSK Investigational Site
Johannesburg, 2001
South AfricaSite Not Available
GSK Investigational Site
Soweto, 1862
South AfricaSite Not Available
GSK Investigational Site
Umlazi, 4066
South AfricaSite Not Available
GSK Investigational Site
Moshi, 3010
TanzaniaSite Not Available
GSK Investigational Site
Bangkok, 10700
ThailandSite Not Available
GSK Investigational Site
Changklan, Muang, 50100
ThailandSite Not Available
GSK Investigational Site
Chiang Mai, 50200
ThailandSite Not Available
GSK Investigational Site
Chiang Rai, 57000
ThailandSite Not Available
GSK Investigational Site
ChiangMai, 50200
ThailandSite Not Available
GSK Investigational Site
Chiangrai, 57000
ThailandSite Not Available
GSK Investigational Site
Muang, 50200
ThailandSite Not Available
GSK Investigational Site
Los Angeles, California 90095
United StatesSite Not Available
GSK Investigational Site
Fort Lauderdale, Florida 33316
United StatesSite Not Available
GSK Investigational Site
Memphis, Tennessee 38105-3678
United StatesSite Not Available
GSK Investigational Site
Harare,
ZimbabweSite Not Available
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