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

This study has been completed.
Study NCT00001117.   Last updated on July 30, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection
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)
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.

Study Phase Phase II
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Hepatitis C
Intervention 
MEDLINE PMIDs 12351951
Links Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  60
Start Date 
Completion Date
Eligibility Criteria 

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.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Puerto Rico
Administrative Information Fields
NCT ID  NCT00001117
Organization ID ACTG 383
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     Raymond Chung        
Study Chair:     Cecilia Shikuma        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date June 2003
First Received Date  November 2, 1999
Last Updated Date July 30, 2008

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




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