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

Information source: ViiV Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Immunodeficiency Virus-1

Intervention: maraviroc (Drug); maraviroc (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: ViiV Healthcare

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naļve HIV-Infected Patients With R5 HIV-1

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)

Secondary outcome:

HIV-1 RNA Levels at Baseline

Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14

Maximum Observed Plasma Concentration (Cmax) of Maraviroc

Minimum Observed Plasma Concentration (Cmin) of Maraviroc

Average Observed Plasma Concentration (Cavg) of Maraviroc

Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96

Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA

Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA

Time to Loss of Virological Response (TLOVR)

Time-Averaged Difference (TAD) in log10 Viral Load

Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96

Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96

Number of Participants With Genotypic Resistance

Number of Participants With Phenotypic Resistance

Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV-1 RNA viral load of ā‰„1,000 copies/mL measured at the Screening Visit.

- CD4 count ā‰„100 cells/mm3 at Screening.

- Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience TrofileĀ® 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.

Locations and Contacts

Pfizer Investigational Site, Berlin 10243, Germany

Pfizer Investigational Site, Berlin 12157, Germany

Pfizer Investigational Site, Frankfurt am Main 60590, Germany

Pfizer Investigational Site, Hamburg 20146, Germany

Pfizer Investigational Site, Koeln 50937, Germany

Pfizer Investigational Site, Muenchen 80335, Germany

Pfizer Investigational Site, Alicante 03010, Spain

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Cordoba 14004, Spain

Pfizer Investigational Site, Madrid 28046, Spain

Pfizer Investigational Site, Sevilla 41013, Spain

Pfizer Investigational Site, L'hospitalet de Llobregat, Barcelona 08907, Spain

Pfizer Investigational Site, Los Angeles, California 90028, United States

Pfizer Investigational Site, Los Angeles, California 90048, United States

Pfizer Investigational Site, Los Angeles, California 90069, United States

Pfizer Investigational Site, Los Angeles, California 90027, United States

Pfizer Investigational Site, Norwalk, Connecticut 06851, United States

Pfizer Investigational Site, Washington, District of Columbia 20009, United States

Pfizer Investigational Site, Miami, Florida 33137, United States

Pfizer Investigational Site, Miami, Florida 33133, United States

Pfizer Investigational Site, Miami, Florida 33136, United States

Pfizer Investigational Site, Orlando, Florida 32803, United States

Pfizer Investigational Site, Pensacola, Florida 32504, United States

Pfizer Investigational Site, St. Petersburg, Florida 33713, United States

Pfizer Investigational Site, Tampa, Florida 33602, United States

Pfizer Investigational Site, Tampa, Florida 33614, United States

Pfizer Investigational Site, Atlanta, Georgia 30312, United States

Pfizer Investigational Site, Chicago, Illinois 60657, United States

Pfizer Investigational Site, Springfield, Massachusetts 01107, United States

Pfizer Investigational Site, Springfield, Massachusetts 01199, United States

Pfizer Investigational Site, Ann Arbor, Michigan 48109, United States

Pfizer Investigational Site, Omaha, Nebraska 68106, United States

Pfizer Investigational Site, New York, New York 10003, United States

Pfizer Investigational Site, Huntersville, North Carolina 28078, United States

Pfizer Investigational Site, Addison, Texas 75001, United States

Pfizer Investigational Site, Dallas, Texas 75390, United States

Pfizer Investigational Site, Dallas, Texas 75204, United States

Pfizer Investigational Site, Houston, Texas 77098, United States

Pfizer Investigational Site, Spokane, Washington 99204, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2009
Last updated: June 8, 2012

Page last updated: August 23, 2015

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