HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | July 26, 2011 |
| End Date: | May 12, 2017 |
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
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.
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.
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)
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)
Inclusion Criteria:
- Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening
- Treatment experience with antiretroviral therapies (excluding integrase inhibitors)
- Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1
μM
- Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3
Exclusion Criteria:
- History (or evidence at Screening) of genotypic resistance to any component of the
study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir
(RAL)]
- Certain laboratory and electrocardiogram (ECG) values
We found this trial at
13
sites
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