NCT01384734

HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label. Arms: 5 (4 BMS-663068 treatment groups and 1 reference group) Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	BMS-663068 400 mg	Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
DRUG	BMS-663068 800 mg	Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
DRUG	BMS-663068 600 mg	Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
DRUG	BMS-663068 1200 mg	Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
DRUG	Raltegravir 400 mg	Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
DRUG	Tenofovir 300 mg	Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
DRUG	Ritonavir 100 mg	Tablets, Oral, 100 mg, Once daily, 96 weeks
DRUG	Atazanavir 300 mg	Capsules, Oral, 300 mg, Once daily, 96 weeks

Timeline

• Start date: 2011-07-26
• Primary completion: 2013-02-18
• Completion: 2017-05-12
• First posted: 2011-06-29
• Last updated: 2018-11-14
• Results posted: 2018-11-14

Locations

54 sites across 10 countries: United States, Argentina, Colombia, Germany, Mexico, Peru, Romania, Russia, South Africa, Spain