CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 enrolled
Drug / intervention
Dolutegravir +1 moredrug
Likely dose
Dolutegravir 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02582684
NCT02582684Phase 2Completed

A Study to Evaluate Dolutegravir Plus Lamivudine Dual Therapy for the Treatment of Naïve HIV-1-infected Participants

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Oct 21, 2015·Updated May 9, 2018

In Brief

A Phase 2 clinical trial evaluating Dolutegravir and Lamivudine for HIV-1 Infection. Completed, enrolled 122 participants across 26 sites in 2 countries.

Detailed Summary

This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV. DTG is a type of HIV medicine called an integrase inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor. DTG works by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV proteins (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of HIV in the blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA) recommended regimens along with a third active drug. Since some HIV medicines have side effects and are costly, there is interest in whether HIV can be successfully controlled with fewer than three HIV drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesPuerto Rico, United States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 21, 2015
Enrollment StartDec 8, 2015
Primary CompletionFeb 28, 2017
Study CompletionSep 26, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.7 years ago

Interventions

Dolutegravirdrug

Participants were prescribed 50 mg of DTG orally daily

Lamivudinedrug

Participants were prescribed 300 mg of 3TC orally daily.