A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
This study has been completed.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00827112
First received: January 21, 2009
Last updated: June 8, 2012
Last verified: June 2012
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Results First Received: July 11, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Human Immunodeficiency Virus-1 |
| Intervention: |
Drug: maraviroc |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Maraviroc+ Atazanavir / Ritonavir | Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks. |
| Atazanavir / Ritonavir + Emtricitabine / Tenofovir | Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks. |
Participant Flow: Overall Study
| Maraviroc+ Atazanavir / Ritonavir | Atazanavir / Ritonavir + Emtricitabine / Tenofovir | |
|---|---|---|
| STARTED | 65 | 64 |
| Treated | 60 | 61 |
| COMPLETED | 50 | 52 |
| NOT COMPLETED | 15 | 12 |
| Adverse Event | 2 | 0 |
| Lack of Efficacy | 2 | 0 |
| Lost to Follow-up | 3 | 2 |
| Pregnancy | 0 | 1 |
| Protocol Violation | 0 | 2 |
| Withdrawal by Subject | 2 | 1 |
| Randomized but not treated | 5 | 3 |
| Unspecified | 1 | 3 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Maraviroc+ Atazanavir / Ritonavir | Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks. |
| Atazanavir / Ritonavir + Emtricitabine / Tenofovir | Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks. |
| Total | Total of all reporting groups |
Baseline Measures
| Maraviroc+ Atazanavir / Ritonavir | Atazanavir / Ritonavir + Emtricitabine / Tenofovir | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
60 | 61 | 121 |
|
Age
[units: Years] Mean ± Standard Deviation |
38.3 ± 10.2 | 35.3 ± 10.5 | 36.8 ± 10.4 |
|
Gender
[units: Participants] |
|||
| Female | 4 | 9 | 13 |
| Male | 56 | 52 | 108 |
Outcome Measures
| 1. Primary: | Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL) [ Time Frame: Week 48 ] |
| 2. Secondary: | HIV-1 RNA Levels at Baseline [ Time Frame: Baseline ] |
| 3. Secondary: | Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14 [ Time Frame: Baseline , Days 4, 7, 10 and 14 ] |
| 4. Secondary: | Maximum Observed Plasma Concentration (Cmax) of Maraviroc [ Time Frame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) ] |
| 5. Secondary: | Minimum Observed Plasma Concentration (Cmin) of Maraviroc [ Time Frame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) ] |
| 6. Secondary: | Average Observed Plasma Concentration (Cavg) of Maraviroc [ Time Frame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) ] |
| 7. Secondary: | Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96 [ Time Frame: Baseline, Week 16, Week 24, Week 48, Week 96 ] |
| 8. Secondary: | Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA [ Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96 ] |
| 9. Secondary: | Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA [ Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96 ] |
| 10. Secondary: | Time to Loss of Virological Response (TLOVR) [ Time Frame: Baseline through Week 96 ] |
| 11. Secondary: | Time-Averaged Difference (TAD) in log10 Viral Load [ Time Frame: Week 16, Week 24, Week 48, Week 96 ] |
| 12. Secondary: | Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96 [ Time Frame: Baseline, Week 16, Week 24, Week 48, Week 96 ] |
| 13. Secondary: | Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96 [ Time Frame: Baseline, Week 16, Week 24, Week 48, Week 96 ] |
| 14. Secondary: | Number of Participants With Genotypic Resistance [ Time Frame: Week 96 or Time of treatment failure ] |
| 15. Secondary: | Number of Participants With Phenotypic Resistance [ Time Frame: Week 96 or Time of treatment failure ] |
| 16. Secondary: | Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay [ Time Frame: Baseline to Week 96 or Time of treatment Failure ] |