- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001068
A Study of Disease Progression and Anti-HIV Treatments
October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
Influence of Risk Status for Disease Progression on the Response to Antiretroviral Interventions: A Follow-up Study to ACTG 175
To determine the influence of virus load, CD4 count, biologic phenotype, and presence of symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen.
PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment for 6 months.
Study Overview
Study Type
Interventional
Enrollment
210
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00936
- Puerto Rico-AIDS CRS
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Mbeya, Tanzania
- Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
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Alabama
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Birmingham, Alabama, United States, 35294
- Alabama Therapeutics CRS
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California
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Los Angeles, California, United States, 90095
- UCLA CARE Center CRS
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Los Angeles, California, United States, 90033
- USC CRS
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Palo Alto, California, United States, 94115
- Stanford CRS
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San Diego, California, United States
- Ucsd, Avrc Crs
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San Francisco, California, United States, 94110
- Ucsf Aids Crs
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San Jose, California, United States, 95128
- Santa Clara Valley Med. Ctr.
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Stanford, California, United States, 94305
- San Mateo County AIDS Program
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Torrance, California, United States, 90502
- Harbor-UCLA Med. Ctr. CRS
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Colorado
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Aurora, Colorado, United States
- University of Colorado Hospital CRS
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Florida
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Miami, Florida, United States, 33136
- Univ. of Miami AIDS CRS
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Georgia
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Atlanta, Georgia, United States, 30365
- Emory Univ. Hemophilia Program Office
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Illinois
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Chicago, Illinois, United States, 60612
- Cook County Hosp. CORE Ctr.
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Chicago, Illinois, United States, 60611
- Northwestern University CRS
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Chicago, Illinois, United States, 60612
- Rush Univ. Med. Ctr. ACTG CRS
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Indiana
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Indianapolis, Indiana, United States
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
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Louisiana
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New Orleans, Louisiana, United States
- Tulane Hemophilia Treatment Ctr.
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Adult AIDS CRS
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital ACTG CRS
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Boston, Massachusetts, United States, 02118
- Bmc Actg Crs
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Boston, Massachusetts, United States
- Beth Israel Deaconess - East Campus A0102 CRS
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Boston, Massachusetts, United States
- Beth Israel Deaconess Med. Ctr., ACTG CRS
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota, ACTU
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Missouri
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Saint Louis, Missouri, United States
- Washington U CRS
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Saint Louis, Missouri, United States
- St. Louis ConnectCare, Infectious Diseases Clinic
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Nebraska
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Omaha, Nebraska, United States, 68198
- Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
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New York
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Buffalo, New York, United States, 14215
- SUNY - Buffalo, Erie County Medical Ctr.
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New York, New York, United States, 10016
- NY Univ. HIV/AIDS CRS
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New York, New York, United States, 10021
- Cornell University A2201
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New York, New York, United States, 10003
- Beth Israel Med. Ctr. (Mt. Sinai)
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Rochester, New York, United States, 14642
- Univ. of Rochester ACTG CRS
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Unc Aids Crs
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Charlotte, North Carolina, United States, 28203
- Carolinas HealthCare System, Carolinas Med. Ctr.
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Greensboro, North Carolina, United States, 27401
- Regional Center for Infectious Disease, Wendover Medical Center CRS
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Ohio
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Cincinnati, Ohio, United States, 45267
- Univ. of Cincinnati CRS
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Cleveland, Ohio, United States, 44106
- Case CRS
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Columbus, Ohio, United States, 43210
- The Ohio State Univ. AIDS CRS
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hosp. of the Univ. of Pennsylvania CRS
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Washington
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Seattle, Washington, United States, 98122
- University of Washington AIDS CRS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Patients must have:
- Prior participation on protocol ACTG 175.
PER AMENDMENT 8/27/96:
- Patients must be on study/on treatment at the time the protocol study treatment is extended.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
October 1, 1998
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Actual)
November 4, 2021
Last Update Submitted That Met QC Criteria
October 28, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG 303
- 11278 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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