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A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection

Completed
Conditions
HIV Infections
Hepatitis C
Registration Number
NCT00001117
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

This study evaluates patients infected with both HIV and Hepatitis C virus (HCV) who are receiving anti-HIV drugs. The purpose of this study is to learn more about HCV infection in patients whose HIV blood level decreases to less than 500 copies/ml.

Detailed Description

Sixty naive patients with HIV and confirmed hepatitis C who are co-enrolled in another AACTG antiretroviral study that involves the testing of HAART (Highly Active Antiretroviral Therapy) are entered on this prospective study. Patients who are defined as naive have never received specific, active antiretroviral agents that sustain viral suppression below the limit of detection (500 copies/ml) or have received those agents for only a very limited time. HAART is defined as therapy which is likely to result in HIV-1 RNA plasma levels less than 500 copies/ml for at least 16 weeks. Plasma is collected and evaluated during the study for additional quantitative measurements: Hepatitis C virus (HCV) by HCV RNA PCR and HIV-1 RNA levels. All evaluations for HIV-1 RNA are obtained from the co-enrolled study at the following time points: Pre-entry, entry, at least 2 measurements before Week 16, Week 16, and at least 1 measurement after Week 16.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (43)

Harbor UCLA Med Ctr

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Torrance, California, United States

Marin County Specialty Clinic

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San Rafael, California, United States

Emory Univ

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Atlanta, Georgia, United States

Harvard (Massachusetts Gen Hosp)

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Boston, Massachusetts, United States

Boston Med Ctr

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Boston, Massachusetts, United States

Univ of Cincinnati

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Cincinnati, Ohio, United States

Louis A Weiss Memorial Hosp

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Chicago, Illinois, United States

Indiana Univ Hosp

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Indianapolis, Indiana, United States

Division of Inf Diseases/ Indiana Univ Hosp

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Indianapolis, Indiana, United States

Johns Hopkins Hosp

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Baltimore, Maryland, United States

Case Western Reserve Univ

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Cleveland, Ohio, United States

Ohio State Univ Hosp Clinic

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Columbus, Ohio, United States

Univ of Pennsylvania at Philadelphia

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Philadelphia, Pennsylvania, United States

Univ of Washington

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Seattle, Washington, United States

Willow Clinic

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Menlo Park, California, United States

Univ of California / San Diego Treatment Ctr

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San Diego, California, United States

San Francisco Gen Hosp

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San Francisco, California, United States

Univ of Colorado Health Sciences Ctr

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Denver, Colorado, United States

Univ of Southern California / LA County USC Med Ctr

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Los Angeles, California, United States

Stanford Univ Med Ctr

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Stanford, California, United States

Howard Univ

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Washington, District of Columbia, United States

Beth Israel Med Ctr

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New York, New York, United States

Northwestern Univ Med School

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Chicago, Illinois, United States

Univ of Texas Galveston

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Galveston, Texas, United States

Columbia Presbyterian Med Ctr

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New York, New York, United States

Chelsea Ctr

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New York, New York, United States

Bellevue Hosp / New York Univ Med Ctr

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New York, New York, United States

San Mateo AIDS Program / Stanford Univ

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Stanford, California, United States

Univ of Hawaii

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Honolulu, Hawaii, United States

St Louis Regional Hosp / St Louis Regional Med Ctr

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St Louis, Missouri, United States

SUNY / Erie County Med Ctr at Buffalo

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Buffalo, New York, United States

Cook County Hosp

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Chicago, Illinois, United States

Queens Med Ctr

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Honolulu, Hawaii, United States

Charity Hosp / Tulane Univ Med School

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New Orleans, Louisiana, United States

Rush Presbyterian - Saint Luke's Med Ctr

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Chicago, Illinois, United States

Univ of Minnesota

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Minneapolis, Minnesota, United States

Univ of Miami School of Medicine

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Miami, Florida, United States

Cornell Univ Med Ctr

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New York, New York, United States

Univ of Puerto Rico

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San Juan, Puerto Rico

Tulane Univ School of Medicine

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New Orleans, Louisiana, United States

Univ of Rochester Medical Center

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Rochester, New York, United States

Univ of North Carolina

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Chapel Hill, North Carolina, United States

Julio Arroyo

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West Columbia, South Carolina, United States

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