Phase 2
N=251
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
Infection, Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT01384734 ↗Enrolled (actual)
251
Serious AEs
17.1%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 — 80; 69; 76; 72 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-663068 400 mg (Drug); BMS-663068 800 mg (Drug); BMS-663068 600 mg (Drug); BMS-663068 1200 mg (Drug); Raltegravir 400 mg (Drug); Tenofovir 300 mg (Drug); Ritonavir 100 mg (Drug); Atazanavir 300 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 |
80; 69; 76; 72; 75 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 |
3; 4; 4; 2; 5; 1 | — |
| SECONDARY Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period |
0.220; 0.149; 0.126; 0.126; -0.340; -0.811 | — |
| SECONDARY Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA |
-0.770; -1.524; -1.250; -1.399 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period |
0; 0; 0; 11 | — |
| SECONDARY Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy |
58.4; 134.8; 71.8; 63.4; 134.2; 216.3 | — |
| SECONDARY Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy |
-0.005; 0.023; 0.008; 0.014; -0.003; -0.040 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study |
82; 61; 69; 68; 71; 78 | — |
| SECONDARY Number of Participants With SAE and Discontinuation Due to AEs During Primary Study |
3; 5; 4; 2; 5; 5 | — |
| SECONDARY Change From Baseline in CD4+ T-cell Count |
134.3; 111.0; 109.5; 124.5; 119.4; 199.1 | — |
| SECONDARY Number of Participants With Newly-emergent Genotypic Substitutions at Week 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Newly-emergent Genotypic Substitutions at Week 48 |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Newly-emergent Genotypic Substitutions at Week 96 |
3; 1; 2; 2; 0; 2 | — |
| SECONDARY Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24 |
-2.350; 1014.748; 101.627; 39.030 | — |
| SECONDARY Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48 |
-2.624; 586.776; 81.729; 449.092 | — |
| SECONDARY Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96 |
25.480; 419.901; 46.351; 777.818 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01384734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.