Clinical trial NCT00001117: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Hepatitis C
Keywords: HIV-1
Drug Therapy, Combination
Hepatitis C
RNA, Viral
Anti-HIV Agents
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univ of Southern California / LA County USC Med Ctr
state: California
city: Menlo Park
country: United States
facility: Willow Clinic
state: California
city: San Diego
country: United States
facility: Univ of California / San Diego Treatment Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: San Rafael
country: United States
facility: Marin County Specialty Clinic
state: California
city: Stanford
country: United States
facility: San Mateo AIDS Program / Stanford Univ
state: California
city: Stanford
country: United States
facility: Stanford Univ Med Ctr
state: California
city: Torrance
country: United States
facility: Harbor UCLA Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Washington
country: United States
facility: Howard Univ
state: District of Columbia
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory Univ
state: Georgia
city: Honolulu
country: United States
facility: Queens Med Ctr
state: Hawaii
city: Honolulu
country: United States
facility: Univ of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Cook County Hosp
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Chicago
country: United States
facility: Louis A Weiss Memorial Hosp
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: Indianapolis
country: United States
facility: Division of Inf Diseases/ Indiana Univ Hosp
state: Indiana
city: New Orleans
country: United States
facility: Charity Hosp / Tulane Univ Med School
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Univ School of Medicine
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Harvard (Massachusetts Gen Hosp)
state: Massachusetts
city: Boston
country: United States
facility: Boston Med Ctr
state: Massachusetts
city: Minneapolis
country: United States
facility: Univ of Minnesota
state: Minnesota
city: St Louis
country: United States
facility: St Louis Regional Hosp / St Louis Regional Med Ctr
state: Missouri
city: Buffalo
country: United States
facility: SUNY / Erie County Med Ctr at Buffalo
state: New York
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Chelsea Ctr
state: New York
city: New York
country: United States
facility: Cornell Univ Med Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Univ of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve Univ
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Univ of Pennsylvania at Philadelphia
state: Pennsylvania
city: West Columbia
country: United States
facility: Julio Arroyo
state: South Carolina
city: Galveston
country: United States
facility: Univ of Texas Galveston
state: Texas
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
city: San Juan
country: Puerto Rico
facility: Univ of Puerto Rico
Study officials:
name: Raymond Chung
role: STUDY_CHAIR
name: Cecilia Shikuma
role: STUDY_CHAIR
References:
citation: 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.