Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

December 5, 2013 updated by: AIDS Clinical Trials Group

Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.

Study Overview

Status

Completed

Conditions

Detailed Description

A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.

No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

Study Type

Observational

Enrollment (Actual)

5982

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

  • Puerto Rico
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico
      • San Juan,, Puerto Rico, 00935
        • Puerto Rico-AIDS CRS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, United States, 900331079
        • Univ of Southern California / LA County USC Med Ctr
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente LAMC
      • Menlo Park, California, United States, 94025
        • Willow Clinic
      • Sacramento, California, United States, 95814
        • UC Davis Med Ctr
      • San Diego, California, United States, 921036325
        • Univ of California / San Diego Treatment Ctr
      • San Francisco, California, United States, 94110
        • Univ of California, San Francisco/San Francisco General Hosp
      • San Jose, California, United States, 951282699
        • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
      • San Rafael, California, United States, 94903
        • Marin County Specialty Clinic
      • Stanford, California, United States, 943055107
        • San Mateo AIDS Program / Stanford Univ
      • Stanford, California, United States, 943055107
        • Stanford Univ Med Ctr
      • Torrance, California, United States, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
      • Denver, Colorado, United States, 80204
        • Denver Public Health CRS
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Univ
      • Atlanta, Georgia, United States, 303652225
        • Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ of Hawaii
      • Tripler AMC, Hawaii, United States, 96859
        • Tripler Army Med Ctr
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ Hosp
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hosp of Indiana / Life Care Clinic
      • Indianapolis, Indiana, United States, 46202
        • Division of Inf Diseases/ Indiana Univ Hosp
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Univ of Iowa Hosp and Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Med Ctr Hosp
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
      • Baltimore, Maryland, United States, 21201
        • IHV Baltimore Treatment CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Harvard (Massachusetts Gen Hosp)
      • Boston, Massachusetts, United States, 02118
        • Boston Med Ctr
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess - West Campus
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ. CRS
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Clinic
    • Missouri
      • St Louis, Missouri, United States, 63112
        • St Louis Regional Hosp / St Louis Regional Med Ctr
    • Nebraska
      • Omaha, Nebraska, United States, 681985130
        • Univ of Nebraska Med Ctr
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Univ. Hosp. CRS
      • Newark, New Jersey, United States, 07103
        • New Jersey Medical School- Adult Clinical Research Ctr. CRS
    • New York
      • Bronx, New York, United States, 10457
        • Bronx-Lebanon Hosp. Ctr. CRS
      • Buffalo, New York, United States, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10021
        • Cornell Univ Med Ctr
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, United States, 10021
        • Chelsea Ctr
      • New York, New York, United States, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10021
        • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
      • Rochester, New York, United States, 14642
        • Univ of Rochester Medical Center
      • Rochester, New York, United States, 14642
        • Community Health Network Inc
      • Rochester,, New York, United States, 14607
        • AIDS Care CRS
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Univ of North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Wake County Department of Health
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Med Ctr
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
      • Greensboro, North Carolina, United States, 27401
        • Moses H Cone Memorial Hosp
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ of Cincinnati
      • Cleveland, Ohio, United States, 441091998
        • MetroHealth Med Ctr
      • Cleveland, Ohio, United States, 44106-5083
        • Cleveland Clinic
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research & Education Group-Portland CRS
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • Presbyterian Medical Center - Univ. of PA
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania at Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Univ of Pittsburgh
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Julio Arroyo
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75390
        • Univ of Texas, Southwestern Med Ctr of Dallas
      • Dallas, Texas, United States, 75215
        • Peabody Health Center CRS
      • Houston, Texas, United States, 77030
        • Houston AIDS Research Team CRS
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth Univ. Medical Ctr. CRS
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington

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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants in this study will be HIV-infected men and women who are enrolled in an ACTG parent study and are receiving HAART.

Description

Inclusion Criteria

  • HIV-1 infected
  • Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study, including the visit window of the parent study. More information on this criterion can be found in the protocol.
  • Willing to provide consent for the release and use of clinical data from the parent study
  • Life expectancy of at least 24 weeks
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria

  • Active alcohol or drug abuse that may interfere with the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successive suppressed viral load measures
Time Frame: Measured 144 weeks after randomization
Measured 144 weeks after randomization
Genotypic or phenotypic resistance
Time Frame: Measured at baseline and study completion
Measured at baseline and study completion
Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater
Time Frame: Measured throughout
Measured throughout
Absolute number and percentage of CD4 and CD8 T cells
Time Frame: Measured 144 weeks after randomization
Measured 144 weeks after randomization
Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells
Time Frame: Measured 144 weeks after randomization
Measured 144 weeks after randomization
Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells
Time Frame: Measured 144 weeks after randomization
Measured 144 weeks after randomization
Levels of immune activation markers, including CD8, CD38, and HLA-DR cells
Time Frame: Measured 144 weeks after randomization
Measured 144 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
HIV-1 latency or replication in tissue or cellular reservoirs
Time Frame: Measured at baseline, Week 16, Week 48, and study completion
Measured at baseline, Week 16, Week 48, and study completion
Syncytium and non-syncytium inducing (SI/NSI) phenotype
Time Frame: Measured at baseline, Week 16, Week 48, and study completion
Measured at baseline, Week 16, Week 48, and study completion
Metabolic and neurologic complications
Time Frame: Measured at baseline, Week 16, Week 48, and study completion
Measured at baseline, Week 16, Week 48, and study completion
Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV
Time Frame: Measured 144 weeks after randomization
Measured 144 weeks after randomization
Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)
Time Frame: Measured at baseline, Week 16, and study completion
Measured at baseline, Week 16, and study completion
Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities
Time Frame: Measured at baseline, Week 48, and study completion
Measured at baseline, Week 48, and study completion
Quality of life scores
Time Frame: Measured at baseline, Week 48, and study completion
Measured at baseline, Week 48, and study completion
Subject-reported patterns of adherence
Time Frame: Measured at baseline, Week 48, and study completion
Measured at baseline, Week 48, and study completion
Estimated inpatient, outpatient, and total costs
Time Frame: Measured at study completion
Measured at study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Clinical Trials Group

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Constance A. Benson, MD, Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
  • Study Chair: Ann C. Collier, MD, University of Washington

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.

General Publications

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 Start

January 1, 2000

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 28, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5001
  • 1U01AI068636 (U.S. NIH Grant/Contract)
  • AACTG A5001

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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