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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.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001117
  Purpose

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.


Condition Phase
HIV Infections
Hepatitis C
Phase II

MedlinePlus related topics: AIDS AIDS Medicines Hepatitis Hepatitis C
U.S. FDA Resources
Study Type: Observational
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)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 60
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001117

  Show 43 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Raymond Chung
Study Chair: Cecilia Shikuma
  More Information

Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG 383
Study First Received: November 2, 1999
Last Updated: July 30, 2008
ClinicalTrials.gov Identifier: NCT00001117  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-1
Drug Therapy, Combination
Hepatitis C
RNA, Viral
Anti-HIV Agents

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Liver Diseases
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Hepatitis C
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009