Completed

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

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What is being collected

Data Collection

Who is being recruted

HIV Infections

+ Hepatitis C
Over 13 Years
How is the trial designed

Other

Observational

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 1, 2008
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleDynamics of Hepatitis C Infection in Subjects With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Receiving Highly Active Antiretroviral Therapy (HAART) 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 1, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Hepatitis C
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 43 locations
Suspended
Univ of Southern California / LA County USC Med CtrLos Angeles, United StatesSee the location
Suspended
Willow ClinicMenlo Park, United States
Suspended
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspended
San Francisco Gen HospSan Francisco, United States

Completed43 Study Centers