CClinicalTrials.gg
CompletedNCT00001117Updated Aug 1, 2008

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

An observational study in HIV Infections and Hepatitis C, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 43 sites in 2 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2008-08-01.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Enrollment
60
Ages
13 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections
  • Hepatitis C

Keywords

  • HIV-1
  • Drug Therapy, Combination
  • Hepatitis C
  • RNA, Viral
  • Anti-HIV Agents
03

In context

Infections

6,686 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 60 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Enrollment
60 participants
06

Study locations

43 sites
  • Univ of Southern California / LA County USC Med Ctr
    Los Angeles, California 900331079, United States
  • Willow Clinic
    Menlo Park, California 94025, United States
  • Univ of California / San Diego Treatment Ctr
    San Diego, California 921036325, United States
  • San Francisco Gen Hosp
    San Francisco, California 941102859, United States
  • Marin County Specialty Clinic
    San Rafael, California 94903, United States
  • San Mateo AIDS Program / Stanford Univ
    Stanford, California 943055107, United States
  • Stanford Univ Med Ctr
    Stanford, California 943055107, United States
  • Harbor UCLA Med Ctr
    Torrance, California 90502, United States
  • Univ of Colorado Health Sciences Ctr
    Denver, Colorado 80262, United States
  • Howard Univ
    Washington, District of Columbia 20059, United States
  • Univ of Miami School of Medicine
    Miami, Florida 331361013, United States
  • Emory Univ
    Atlanta, Georgia 30308, United States
  • Queens Med Ctr
    Honolulu, Hawaii 96816, United States
  • Univ of Hawaii
    Honolulu, Hawaii 96816, United States
  • Northwestern Univ Med School
    Chicago, Illinois 60611, United States
  • Cook County Hosp
    Chicago, Illinois 60612, United States
  • Rush Presbyterian - Saint Luke's Med Ctr
    Chicago, Illinois 60612, United States
  • Louis A Weiss Memorial Hosp
    Chicago, Illinois 60640, United States
  • Indiana Univ Hosp
    Indianapolis, Indiana 462025250, United States
  • Division of Inf Diseases/ Indiana Univ Hosp
    Indianapolis, Indiana 46202, United States
  • Charity Hosp / Tulane Univ Med School
    New Orleans, Louisiana 70112, United States
  • Tulane Univ School of Medicine
    New Orleans, Louisiana 70112, United States
  • Johns Hopkins Hosp
    Baltimore, Maryland 21287, United States
  • Harvard (Massachusetts Gen Hosp)
    Boston, Massachusetts 02114, United States
  • Boston Med Ctr
    Boston, Massachusetts 02118, United States
  • Univ of Minnesota
    Minneapolis, Minnesota 55455, United States
  • St Louis Regional Hosp / St Louis Regional Med Ctr
    St Louis, Missouri 63112, United States
  • SUNY / Erie County Med Ctr at Buffalo
    Buffalo, New York 14215, United States
  • Beth Israel Med Ctr
    New York, New York 10003, United States
  • Bellevue Hosp / New York Univ Med Ctr
    New York, New York 10016, United States
  • Chelsea Ctr
    New York, New York 10021, United States
  • Cornell Univ Med Ctr
    New York, New York 10021, United States
  • Columbia Presbyterian Med Ctr
    New York, New York 10032, United States
  • Univ of Rochester Medical Center
    Rochester, New York 14642, United States
  • Univ of North Carolina
    Chapel Hill, North Carolina 275997215, United States
  • Univ of Cincinnati
    Cincinnati, Ohio 452670405, United States
  • Case Western Reserve Univ
    Cleveland, Ohio 44106, United States
  • Ohio State Univ Hosp Clinic
    Columbus, Ohio 432101228, United States
  • Univ of Pennsylvania at Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Julio Arroyo
    West Columbia, South Carolina 29169, United States
  • Univ of Texas Galveston
    Galveston, Texas 775550435, United States
  • Univ of Washington
    Seattle, Washington 98104, United States
  • Univ of Puerto Rico
    San Juan, 009365067, Puerto Rico
07

References and documents

Publications

  • Chung RT, Evans SR, Yang Y, Theodore D, Valdez H, Clark R, Shikuma C, Nevin T, Sherman KE; AIDS Clinical Trials Group 383 Study Team. Immune recovery is associated with persistent rise in hepatitis C virus RNA, infrequent liver test flares, and is not impaired by hepatitis C virus in co-infected subjects. AIDS. 2002 Sep 27;16(14):1915-23. doi: 10.1097/00002030-200209270-00008. PubMed 12351951 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00001117
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Aug 31, 2001
Last update
Aug 1, 2008

Study contacts

Raymond Chung
study chair
Cecilia Shikuma
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2003. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion