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NCT00001117 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Dynamics of Hepatitis C Infection in Subjects With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Receiving Highly Active Antiretroviral Therapy (HAART)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001117
Other study ID # ACTG 383
Secondary ID
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated July 30, 2008

Study information
Verified date June 2003
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV-positive and have Hepatitis C.

- Have an HIV blood level of at least 2,500 copies/ml 30 days before study entry.

- Are co-enrolled in an active adult AIDS clinical trial using anti-HIV treatment.

- Are at least 13 years of age (parent or guardian consent required if under 18).

Exclusion Criteria

Patients will not be eligible for this study if they:

- Have liver disease.

- Have cancer requiring chemotherapy.

- Have Hepatitis B.

- Abuse alcohol and/or drugs.

- Have received certain antiretroviral (anti-HIV) drugs in the past.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Univ of Puerto Rico San Juan
United States Emory Univ Atlanta Georgia
United States Johns Hopkins Hosp Baltimore Maryland
United States Boston Med Ctr Boston Massachusetts
United States Harvard (Massachusetts Gen Hosp) Boston Massachusetts
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Cook County Hosp Chicago Illinois
United States Louis A Weiss Memorial Hosp Chicago Illinois
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Case Western Reserve Univ Cleveland Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Univ of Texas Galveston Galveston Texas
United States Queens Med Ctr Honolulu Hawaii
United States Univ of Hawaii Honolulu Hawaii
United States Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana
United States Indiana Univ Hosp Indianapolis Indiana
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Willow Clinic Menlo Park California
United States Univ of Miami School of Medicine Miami Florida
United States Univ of Minnesota Minneapolis Minnesota
United States Charity Hosp / Tulane Univ Med School New Orleans Louisiana
United States Tulane Univ School of Medicine New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr New York New York
United States Chelsea Ctr New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Cornell Univ Med Ctr New York New York
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States Univ of Rochester Medical Center Rochester New York
United States Univ of California / San Diego Treatment Ctr San Diego California
United States San Francisco Gen Hosp San Francisco California
United States Marin County Specialty Clinic San Rafael California
United States Univ of Washington Seattle Washington
United States St Louis Regional Hosp / St Louis Regional Med Ctr St Louis Missouri
United States San Mateo AIDS Program / Stanford Univ Stanford California
United States Stanford Univ Med Ctr Stanford California
United States Harbor UCLA Med Ctr Torrance California
United States Howard Univ Washington District of Columbia
United States Julio Arroyo West Columbia South Carolina

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Chung RT, Evans SR, Yang Y, Theodore D, Valdez H, Clark R, Shikuma C, Nevin T, Sherman KE; AIDS Clinical Trials Group 383 Study Team. Immune recovery is associated with persistent rise in hepatitis C virus RNA, infrequent liver test flares, and is not impaired by hepatitis C virus in co-infected subjects. AIDS. 2002 Sep 27;16(14):1915-23. — View Citation

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