A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 21, 2009

Last Updated Date

May 5, 2009

Start Date ^†

March 2009

Current Primary Outcome Measures ^†

The percentage of patients with plasma HIV-1 RNA <50 copies/mL in each treatment arm at 48 weeks [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00827112 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Safety and tolerability of the treatment with novel combinations of maraviroc (Selzentry, Celsentri with atazanavir/ritonavir; and another combination regimen (atazanavir and emtricitabine/tenofovir) in treatment-naïve HIV-1 infected subjects [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Plasma HIV RNA of the first 15 patients enrolled in two treatment arms at Days 4, 7, 10, and 14 (in US sites only) [ Time Frame: Days 4, 7, 10, and 14 ] [ Designated as safety issue: No ]
PK of maraviroc of the patients enrolled in maraviroc arm [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Virological Response [ Time Frame: wk 16,24,48 ] [ Designated as safety issue: No ]
Immunological Response [ Time Frame: wk 16,24,48 ] [ Designated as safety issue: No ]
Evolution of viral resistance and tropism [ Time Frame: at the time of treatment failure ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Human Immunodeficiency Virus-1

Intervention ^†

Drug: maraviroc

Study Arms / Comparison Groups

Experimental: maraviroc 150 mg QD + atazanavir/ritonavir 300/100mg QD
Experimental: atazanavir/ritonavir 300/100 mg QD + emtricitabine/tenofovir 200/300mg QD;

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

February 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00827112

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.