Phase 2
Completed N=129
A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
Human Immunodeficiency Virus-1
Source: ClinicalTrials.gov NCT00827112 ↗
Enrolled (actual)
129
Serious AEs
19.8%
Results posted
Nov 2011
Primary outcomePrimary: Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL) — 74.60; 83.60 Percentage of participants
Summary
This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL) |
74.60; 83.60 | — |
| SECONDARY HIV-1 RNA Levels at Baseline |
84982; 114827 | — |
| SECONDARY Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14 |
1800.00; -46479.40; -36947.90; -52137.10; -58595.80; -54925.90 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Maraviroc |
650 | — |
| SECONDARY Minimum Observed Plasma Concentration (Cmin) of Maraviroc |
37.0 | — |
| SECONDARY Average Observed Plasma Concentration (Cavg) of Maraviroc |
185.10 | — |
| SECONDARY Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96 |
84982; 114827; -89859.1; -107684.6; -87241.2; -110498.1 | — |
| SECONDARY Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA |
0; 6.60; 8.50; 21.30; 47.50; 42.60 | — |
| SECONDARY Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA |
27.12; 34.43; 50.85; 52.46; 79.66; 77.05 | — |
| SECONDARY Time to Loss of Virological Response (TLOVR) |
436.2; 463.8 | — |
| SECONDARY Time-Averaged Difference (TAD) in log10 Viral Load |
-2.459; -2.402; -2.663; -2.626; -2.897; -2.868 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96 |
357.70; 390.00; 169.60; 139.80; 188.90; 173.30 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96 |
931.10; 1125.60; 63.70; -153.80; 6.20; -178.00 | — |
| SECONDARY Number of Participants With Genotypic Resistance |
0; 0 | — |
| SECONDARY Number of Participants With Phenotypic Resistance |
0; 0 | — |
| SECONDARY Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay |
60; 61; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-1 RNA viral load of ≥1, 000 copies/mL measured at the Screening Visit.
- CD4 count ≥100 cells/mm3 at Screening.
- Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.
Exclusion Criteria
- Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
- Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.
- X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.
Data sourced from ClinicalTrials.gov (NCT00827112). 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. Informational only — not medical advice.