HIV InfectionsNCT00001117
A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection
An observational study of HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 43 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Hepatitis C
- How many people
- 60 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States42 sites
Emory Univ
Atlanta, Georgia, 30308
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
Boston Med Ctr
Boston, Massachusetts, 02118
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Case Western Reserve Univ
Cleveland, Ohio, 44106
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Univ of Texas Galveston
Galveston, Texas, 775550435
Queens Med Ctr
Honolulu, Hawaii, 96816
Univ of Hawaii
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Willow Clinic
Menlo Park, California, 94025
Univ of Miami School of Medicine
Miami, Florida, 331361013
Univ of Minnesota
Minneapolis, Minnesota, 55455
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Chelsea Ctr
New York, New York, 10021
Cornell Univ Med Ctr
New York, New York, 10021
Columbia Presbyterian Med Ctr
New York, New York, 10032
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco Gen Hosp
San Francisco, California, 941102859
Marin County Specialty Clinic
San Rafael, California, 94903
Univ of Washington
Seattle, Washington, 98104
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
Stanford Univ Med Ctr
Stanford, California, 943055107
Harbor UCLA Med Ctr
Torrance, California, 90502
Howard Univ
Washington D.C., District of Columbia, 20059
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
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)
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.
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- HIV-1, Drug Therapy, Combination, Hepatitis C, RNA, Viral, Anti-HIV Agents
- Medical subject headings
- HIV Infections, Hepatitis C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Raymond Chung, Study chairCecilia Shikuma, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001117
- Sponsor's protocol ID
- ACTG 383
- Status last verified
- Jun 2003
- First submitted
- 2 Nov 1999
- Last updated
- 1 Aug 2008
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00001117
- Acronym / sponsor ID
- ACTG 383
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- HIV-1, Drug Therapy, Combination, Hepatitis C, RNA, Viral, Anti-HIV Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2008.
- Background: PubMed 12351951Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Chung study chair
Cecilia Shikuma study chair
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 43 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2008.