A Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-, NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed (study 201636)

Phase 3

Completed

Conditions: HIV1
HIV
10047438

Registration Number: NL-OMON47247

Lead Sponsor: ViiV Healthcare UK Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• HIV1-infected males and females, 18 years and above.
• Uninterrupted current regimen (either the initial or second cART regimen) for at least 6 months.
Acceptable stable cART regimens prior to Screening include 2 NRTIs plus:
• INI
• NNRTI
• PI
See protocol section 5.1 (inclusion criteria) for details.
• Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening.
• Plasma HIV-1 RNA <50 c/mL at Screening.
• Females of childbearing potential: adequate method of contraception during study, see protocol section 5.1, item 5.

Exclusion Criteria

• Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement >=50 c/mL
• Within the 6 to 12 month window prior to Screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL or 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
• Any drug holiday during the window between initiating first HIV ART and 6 months prior to Screening. Exceptions: see protocol section 5.2, item 4..
• Any switch to a 2nd line regimen due to virologic failure to therapy. See protocol section 5.2, item 5 for details.
• Pregnancy or breastfeeding.
• Any evidence of an active CDC Category C disease. Exceptions: see protocol section 5.2, item 7 for details.
• Severe hepatic impairement, unstable liver disease, evidence of Hepatitis B virus. See protocol section 5.2, item 8 for details.
• Exclusionary treatments: medications associated with Torsades de Pointes, HIV-1 immunotherapeutic vaccine, radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulators that alter immune responses, experimental drug or vaccine, any regimen consisting of only single NNRTI therapy or only single or dual NRTI therapy prior to starting cART, ETR, prohibited medication listed in protocol section 6.8.2. See protocol section 5.2, item 17-25 and 6.8.2 for details (e.g. interval until screening).
• Evidence of viral resistance. See protocol section 5.2, item 26 for details.
• Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>% of subjects with plasma HIV-1 RNA <50 copies/mL at week 48.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>CD4+ lymphocyte count, % of subjects with plasma HIV-1 RNA <50 copies/mL at<br /><br>week 24, adverse events, premature discontinuation rate, change in biomarkers<br /><br>and lipids, incidence of resistance, pre-dose plasma concentrations. Previously<br /><br>mentioned variables by 3rd agent treatment class. Symptom distress module, HIV<br /><br>TSQ, </p><br>