Dynamics of Hepatitis C Infection in Subjects With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Receiving Highly Active Antiretroviral Therapy (HAART)
Data Collection
Blood-Borne Infections+17
+ Urogenital Diseases
+ Genital Diseases
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total 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.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Univ of Southern California / LA County USC Med Ctr
Los Angeles, United StatesOpen Univ of Southern California / LA County USC Med Ctr in Google MapsWillow Clinic
Menlo Park, United StatesUniv of California / San Diego Treatment Ctr
San Diego, United StatesSan Francisco Gen Hosp
San Francisco, United States