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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00827112

Purpose

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.

Condition	Intervention	Phase
Human Immunodeficiency Virus-1	Drug: maraviroc	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Ritonavir BMS 232632 Atazanavir sulfate Maraviroc

U.S. FDA Resources

Further study details as provided by Pfizer:

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 ]

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 ]

Estimated Enrollment:	88
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental maraviroc 150 mg QD + atazanavir/ritonavir 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir/ritonavir without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.	Drug: maraviroc maraviroc 150mg QD + atazanavir/ritonavir (300/100mg) QD OR maraviroc 150mg QD+ darunavir/ritonavir (800/100 mg) QD (if atazanavir/ritonavir is replaced by darunavir/ritonavir) OR maraviroc 150mg QD+ lopinavir/ritonavir (400/100 mg) BID (if atazanavir/ritonavir is replaced by lopinavir/ritonavir)
Arm B: Experimental emtricitabine/tenofovir 200/300mg QD + atazanavir/ritonavir 300/100 mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir/ritonavir without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.	Drug: maraviroc emtricitabine/tenofovir 200/300mg QD + atazanavir/ritonavir 300/100 mg QD OR emtricitabine/tenofovir 200/300 mg QD + darunavir/ritonavir (800/100 mg) QD (if atazanavir/ritonavir is replaced by darunavir/ritonavir) OR emtricitabine/tenofovir 200/300 mg QD + lopinavir/ritonavir (400/100 mg) BID (if atazanavir/ritonavir is replaced by lopinavir/ritonavir)

Arms

Assigned Interventions

Arm A: Experimental

maraviroc 150 mg QD + atazanavir/ritonavir 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir/ritonavir without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.

Drug: maraviroc

maraviroc 150mg QD + atazanavir/ritonavir (300/100mg) QD OR maraviroc 150mg QD+ darunavir/ritonavir (800/100 mg) QD (if atazanavir/ritonavir is replaced by darunavir/ritonavir) OR maraviroc 150mg QD+ lopinavir/ritonavir (400/100 mg) BID (if atazanavir/ritonavir is replaced by lopinavir/ritonavir)

Arm B: Experimental

emtricitabine/tenofovir 200/300mg QD + atazanavir/ritonavir 300/100 mg QD

Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir/ritonavir without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.

Drug: maraviroc

emtricitabine/tenofovir 200/300mg QD + atazanavir/ritonavir 300/100 mg QD OR emtricitabine/tenofovir 200/300 mg QD + darunavir/ritonavir (800/100 mg) QD (if atazanavir/ritonavir is replaced by darunavir/ritonavir)

OR emtricitabine/tenofovir 200/300 mg QD + lopinavir/ritonavir (400/100 mg) BID (if atazanavir/ritonavir is replaced by lopinavir/ritonavir)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827112

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 41 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4001078
Study First Received:	January 21, 2009
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00827112 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

CCR5-tropic HIV-1 virus

Study placed in the following topic categories:

Anti-Infective Agents
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Darunavir
Protease Inhibitors

Virus Diseases
Anti-Retroviral Agents
Emtricitabine
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Atazanavir
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Emtricitabine
HIV Infections
Ritonavir
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 11, 2009