Trials / Terminated
TerminatedNCT04900038
A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults
A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve Adults
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- ViiV Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the efficacy of GSK3640254 + DTG relative to lamivudine (3TC) + DTG in treatment-naïve adult participants living with human immunodeficiency virus (HIV)-1. The participants were randomized to one of the three doses of blinded GSK3640254 (100, 150, or 200 milligrams \[mgs\]) or a reference arm of blinded 3TC-each in combination with open label DTG.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK3640254 | GSK3640254 was available as 25 mg or 100 mg tablets administered orally. |
| DRUG | Dolutegravir | DTG was available as 50 mg tablets administered orally. |
| DRUG | Lamivudine capsules | 3TC was available as 300 mg capsules administered orally as a blinded treatment. |
| DRUG | Lamivudine tablets | 3TC was available as 300 mg tablets administered orally as an unblinded treatment. |
Timeline
- Start date
- 2021-08-18
- Primary completion
- 2022-11-22
- Completion
- 2023-05-11
- First posted
- 2021-05-25
- Last updated
- 2023-12-14
- Results posted
- 2023-12-14
Locations
44 sites across 10 countries: United States, Argentina, Canada, France, Germany, Italy, Portugal, Puerto Rico, South Africa, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04900038. Inclusion in this directory is not an endorsement.