Clinical trial NCT00827112: A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
Official title: Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Human Immunodeficiency Virus-1
Keywords: CCR5-tropic HIV-1 virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-01-22
Enrollment: 129
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
timeFrame: Week 48
Secondary outcomes:
measure: HIV-1 RNA Levels at Baseline
timeFrame: Baseline
measure: Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
timeFrame: Baseline , Days 4, 7, 10 and 14
measure: Maximum Observed Plasma Concentration (Cmax) of Maraviroc
timeFrame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
measure: Minimum Observed Plasma Concentration (Cmin) of Maraviroc
timeFrame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
measure: Average Observed Plasma Concentration (Cavg) of Maraviroc
timeFrame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
measure: Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
timeFrame: Baseline, Week 16, Week 24, Week 48, Week 96
measure: Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
timeFrame: 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
measure: Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
timeFrame: 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
measure: Time to Loss of Virological Response (TLOVR)
timeFrame: Baseline through Week 96
measure: Time-Averaged Difference (TAD) in log10 Viral Load
timeFrame: Week 16, Week 24, Week 48, Week 96
measure: Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
timeFrame: Baseline, Week 16, Week 24, Week 48, Week 96
measure: Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
timeFrame: Baseline, Week 16, Week 24, Week 48, Week 96
measure: Number of Participants With Genotypic Resistance
timeFrame: Week 96 or Time of treatment failure
measure: Number of Participants With Phenotypic Resistance
timeFrame: Week 96 or Time of treatment failure
measure: Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
timeFrame: Baseline to Week 96 or Time of treatment Failure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Norwalk
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Huntersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Addison
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt am Main
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: L'hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: