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HIV Transmission Risk Behavior Substudy
The purpose of this study is to compare the effects of two different anti-HIV drug regimens on HIV transmission risk behavior among SMART study participants.
It is important to consider the role that HIV infected individuals play in ongoing HIV transmission. Different anti-HIV treatment regimens may lead to variations in HIV transmission risk behavior among HIV infected individuals. HIV infected people with viral loads of less than 1,000 copies/ml are less likely to transmit HIV through heterosexual sex. However, condom use sometimes decreases after individuals start combination antiretroviral therapy (ART); also, some studies have shown an increased rate in acquiring sexually transmitted infections (STIs) following initiation of ART, and those on ART may transmit a drug-resistant strain of HIV. In the SMART study, participants were randomly assigned to one of two treatment groups: * Group 1 participants will follow a drug conservation (DC) regimen in which ART will be stopped or deferred until CD4 cell count drops below 250 cells/mm3, will be initiated until CD4 cell count is at least 350 cells/mm3, and then will be followed by episodic ART based on CD4 cell count. * Group 2 participants will follow a viral suppression (VS) regimen in which ART is continued to keep viral loads as low as possible, regardless of CD4 cell count. The purpose of this study is to compare how the DC and VS regimens affect HIV transmission risk behavior among SMART study participants. At baseline, participants will complete a questionnaire about their sexual behavior during the previous 2 months. They will also undergo urine and blood collection for STI testing. These same procedures will occur at Months 4 and 12, then every year thereafter for the first 4 years that a participant is in the parent study. Participants and their physicians will be notified of STI testing results so that patients can be referred to appropriate care.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
AIDS Healthcare Foundation CRS
Beverly Hills, California, United States
UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS
Fresno, California, United States
Dr. M. Estes Med. Practice CRS
Mill Valley, California, United States
Dr. Robert Scott Med. Practice CRS
Oakland, California, United States
East Bay AIDS Ctr. CRS
Oakland, California, United States
Dr. Shawn Hassler Med. Practice CRS
San Francisco, California, United States
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
San Francisco, California, United States
Dr. Virginia Cafaro Med. Practice CRS
San Francisco, California, United States
Dr. William Owen Med. Practice CRS
San Francisco, California, United States
Castro-Mission Health Ctr. CRS
San Francisco, California, United States
Start Date
January 1, 2002
Primary Completion Date
January 1, 2006
Completion Date
September 1, 2008
Last Updated
April 17, 2014
883
ACTUAL participants
Delayed ART
DRUG
Continuous ART
DRUG
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330