HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs
Virologic Studies in Compartmental Samples From HIV-Infected Subjects Changing or Initiating Potent Antiretroviral Therapy
3 other identifiers
observational
164
1 country
23
Brief Summary
The purpose of this study is to gain information on how the type and amount of HIV present in certain places in the body and in the blood are affected when potent (powerful) anti-HIV drugs are given. Researchers know that the type and amount of HIV may differ in certain places in the body (called compartments) but are not sure how anti-HIV treatment affects these differences. This study gathers information to help understand how the virus grows and changes between blood and nonblood compartments in patients receiving anti-HIV treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2000
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
December 23, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedNovember 20, 2013
November 1, 2013
December 23, 2000
November 19, 2013
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are at least 13 years old.
- Are HIV-positive.
- Are changing or beginning anti-HIV therapy (not provided by the study). Anti-HIV therapy should be an approved 3-drug combination.
- Have a viral load of at least 2,000 copies/ml within 60 days of study entry.
- Have signed consent of parent or guardian if under 18 years of age.
- Are willing to contribute samples of blood, saliva, and either genital fluids or lymph tissue, or both, at study visits.
- Are willing to give permission to allow records from any coenrolled studies to be used while participating in this study.
- Have a negative pregnancy test within 14 days of study entry, if women able to have children. Women who become pregnant while on the study are allowed only to contribute blood and saliva samples until the pregnancy ends. After the pregnancy has ended, collection of genital fluids and/or lymphoid tissue will continue.
- Agree to receive HIV-related care at an AACTG site, if not enrolled in another AACTG trial.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have had any active opportunistic (AIDS-related) infection or disease, or have another illness occurring at the same time, or other infections, including an active lower genital tract infection that requires a new drug or change in drug in 14 days or less before study entry. There may be an exception for some conditions.
- Have used immunomodulatory agents in 14 days or less before study entry.
- Have had an immunization in 14 days or less before study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Willow Clinic
Menlo Park, California, 94025, United States
Univ of California, San Diego
San Diego, California, 92103, United States
University of California San Francisco
San Francisco, California, 941104206, United States
Univ of California San Francisco
San Francisco, California, 94110, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington Univ / St Louis Connect Care
St Louis, Missouri, 63108, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Community Health Network Inc
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Univ of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
Kantor R, Bettendorf D, Bosch RJ, Mann M, Katzenstein D, Cu-Uvin S, D'Aquila R, Frenkel L, Fiscus S, Coombs R; ACTG A5077 Study Team. HIV-1 RNA levels and antiretroviral drug resistance in blood and non-blood compartments from HIV-1-infected men and women enrolled in AIDS clinical trials group study A5077. PLoS One. 2014 Apr 3;9(4):e93537. doi: 10.1371/journal.pone.0093537. eCollection 2014.
PMID: 24699474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alejo Erice
- STUDY CHAIR
Robert Coombs
- STUDY CHAIR
Susan Fiscus
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 23, 2000
First Posted
August 31, 2001
Study Start
November 1, 2000
Study Completion
August 1, 2004
Last Updated
November 20, 2013
Record last verified: 2013-11