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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
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
HIV-1 RNA Levels at Baseline
Time frame: Baseline
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.
Time frame: Baseline , Days 4, 7, 10 and 14
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)
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)
Average Observed Plasma Concentration (Cavg) of Maraviroc
Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).
Time frame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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
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
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Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Norwalk, Connecticut, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
...and 29 more locations
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
Time to Loss of Virological Response (TLOVR)
TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.
Time frame: Baseline through Week 96
Time-Averaged Difference (TAD) in log10 Viral Load
TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).
Time frame: Week 16, Week 24, Week 48, Week 96
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
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
Number of Participants With Genotypic Resistance
Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Time frame: Week 96 or Time of treatment failure
Number of Participants With Phenotypic Resistance
Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Time frame: Week 96 or Time of treatment failure
Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} \[X4\]-using HIV-1 RNA represented 0.3 percent of the total viral population.
Time frame: Baseline to Week 96 or Time of treatment Failure