Effects of Two Anti-HIV Drug Regimens on HIV Transmission Risk Behavior Among SMART Study Participants
- Conditions
- HIV Infections
- Interventions
- Drug: Delayed ARTDrug: Continuous ART
- Registration Number
- NCT00386035
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 883
- Coenrollment in the SMART study
- Parent or guardian willing to provide informed consent, if applicable
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1: DC Group Delayed ART HIV infected participants who will stop or defer ART until the CD4 cell count drops below 250 cells/mm3 and who discontinue ART when CD4 cell count reaches above 350 cells/mm3. Participants are followed by episodic ART based on CD4 cell count. 2: VS Group Continuous ART HIV infected participants who continue ART to keep viral loads as low as possible, regardless of CD4 cell count.
- Primary Outcome Measures
Name Time Method To compare the DC group to the VS group for HIV transmission and risk behaviors At the end of study
- Secondary Outcome Measures
Name Time Method To compare the DC and VS groups for HIV transmission risk behavior in subgroups defined by age, gender, possible transmission category, HIV RNA level, and baseline genotypic resistance pattern. At the end of study To evaluate the correlation between self-reported transmission risk behavior and the acquisition of certain sexually transmitted diseases as specified in the protocol. At the end of study To develop analytic techniques to combine behavioral and biological data into a measure of overall transmission risk At the end of study To evaluate the correlation between self-reported adherence to ART and HIV transmission risk behavior for participants on ART At the end of study To compare the VS group to the DC group on HIV transmission risk behavior in participants who are not on ART at enrollment At the end of study To compare the effects of continuing ART in the VS group to stopping ART in the DC group on HIV transmission risk behavior among participants who are on ART at enrollment At the end of study
Trial Locations
- Locations (58)
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
Scroll for more (48 remaining)AIDS Healthcare Foundation CRS🇺🇸Beverly Hills, California, United States