Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001117
Status:
COMPLETED
Last Update Posted:
2008-08-01
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 copiesml
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 copiesml 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 copiesml 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: