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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. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Observational | ||||||||
| Study Design † | |||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections Hepatitis C |
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| Intervention † | |||||||||
| MEDLINE PMIDs | 12351951 | ||||||||
| Links | Haga clic aquí para ver información sobre este ensayo clínico en español.  |
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| 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:
Exclusion Criteria Patients will not be eligible for this study if they:
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| 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 † |
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| 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 | ||||||||
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