CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 254 enrolled
Drug / intervention
BMS-663068 400 mg +7 moredrug
Likely dose
BMS-663068 400 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/NCT01384734
NCT01384734Phase 2Completed
CompareCT.gov

A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose

ViiV Healthcare·interventional·Posted Jun 29, 2011·Updated Nov 14, 2018

In Brief

A Phase 2 clinical trial evaluating BMS-663068 400 mg, BMS-663068 800 mg, and 6 other interventions for Infection, Human Immunodeficiency Virus. Completed, enrolled 254 participants across 54 sites in 10 countries.

Detailed Summary

The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Human Immunodeficiency Virus
CountriesArgentina, Colombia, Germany, Mexico, Peru, Romania, Russia, South Africa, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2011
Enrollment StartJul 26, 2011
Primary CompletionFeb 18, 2013
Study CompletionMay 12, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.0 years ago

Interventions

BMS-663068 400 mgdrug

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

BMS-663068 800 mgdrug

Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

BMS-663068 600 mgdrug

Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

BMS-663068 1200 mgdrug

Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Raltegravir 400 mgdrug

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Tenofovir 300 mgdrug

Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Ritonavir 100 mgdrug

Tablets, Oral, 100 mg, Once daily, 96 weeks

Atazanavir 300 mgdrug

Capsules, Oral, 300 mg, Once daily, 96 weeks