A Study of Disease Progression and Anti-HIV Treatments

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

Status

Completed

Conditions

Intervention / Treatment

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

      • San Juan, Puerto Rico, 00936
        • Puerto Rico-AIDS CRS
      • Mbeya, Tanzania
        • Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Alabama Therapeutics CRS
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Center CRS
      • Los Angeles, California, United States, 90033
        • USC CRS
      • Palo Alto, California, United States, 94115
        • Stanford CRS
      • San Diego, California, United States
        • Ucsd, Avrc Crs
      • San Francisco, California, United States, 94110
        • Ucsf Aids Crs
      • San Jose, California, United States, 95128
        • Santa Clara Valley Med. Ctr.
      • Stanford, California, United States, 94305
        • San Mateo County AIDS Program
      • Torrance, California, United States, 90502
        • Harbor-UCLA Med. Ctr. CRS
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado Hospital CRS
    • Florida
      • Miami, Florida, United States, 33136
        • Univ. of Miami AIDS CRS
    • Georgia
      • Atlanta, Georgia, United States, 30365
        • Emory Univ. Hemophilia Program Office
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp. CORE Ctr.
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
      • Chicago, Illinois, United States, 60612
        • Rush Univ. Med. Ctr. ACTG CRS
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Louisiana
      • New Orleans, Louisiana, United States
        • Tulane Hemophilia Treatment Ctr.
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Adult AIDS CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ACTG CRS
      • Boston, Massachusetts, United States, 02118
        • Bmc Actg Crs
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess - East Campus A0102 CRS
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Med. Ctr., ACTG CRS
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota, ACTU
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington U CRS
      • Saint Louis, Missouri, United States
        • St. Louis ConnectCare, Infectious Diseases Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
    • New York
      • Buffalo, New York, United States, 14215
        • SUNY - Buffalo, Erie County Medical Ctr.
      • New York, New York, United States, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, United States, 10021
        • Cornell University A2201
      • New York, New York, United States, 10003
        • Beth Israel Med. Ctr. (Mt. Sinai)
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Unc Aids Crs
      • Charlotte, North Carolina, United States, 28203
        • Carolinas HealthCare System, Carolinas Med. Ctr.
      • Greensboro, North Carolina, United States, 27401
        • Regional Center for Infectious Disease, Wendover Medical Center CRS
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Univ. of Cincinnati CRS
      • Cleveland, Ohio, United States, 44106
        • Case CRS
      • Columbus, Ohio, United States, 43210
        • The Ohio State Univ. AIDS CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
    • Washington
      • Seattle, Washington, United States, 98122
        • University of Washington AIDS CRS

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

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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