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 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 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
Trial Locations
- Locations (58)
UCSF PHP, Gen. Internal Medicine Practice CRS
🇺🇸San Francisco, California, United States
Miami VAMC CRS
🇺🇸Miami, Florida, United States
Dr. Shawn Hassler 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
Philadelphia FIGHT - Dr. Jay Kostman CRS
🇺🇸Philadelphia, Pennsylvania, United States
Temple Univ. School of Medicine CRS
🇺🇸Philadelphia, Pennsylvania, United States
Harper Hosp., Detroit CRS
🇺🇸Detroit, Michigan, United States
Dr. Robert Scott Med. Practice CRS
🇺🇸Oakland, California, United States
Dr. M. Estes Med. Practice CRS
🇺🇸Mill Valley, California, United States
UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS
🇺🇸Fresno, California, United States
Dr. Virginia Cafaro Med. Practice CRS
🇺🇸San Francisco, California, United States
San Francisco VAMC, Infectious Diseases Clinic CRS
🇺🇸San Francisco, California, United States
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
🇺🇸San Francisco, California, United States
Western Infectious Disease Consultants CRS
🇺🇸Wheat Ridge, Colorado, United States
Bronx-Lebanon Hosp. Ctr. CRS
🇺🇸Bronx, New York, United States
Detroit Community Health Connection, Inc. CRS
🇺🇸Detroit, Michigan, United States
Montefiore Med. Ctr., AIDS Ctr. CRS
🇺🇸Bronx, New York, United States
PeaceHealth Med. Group - Hilyard Street Clinic CRS
🇺🇸Eugene, Oregon, United States
Albert Einstein Med. Ctr., Immunodeficiency Ctr. CRS
🇺🇸Philadelphia, Pennsylvania, United States
MediCorp, Infectious Disease Associates CRS
🇺🇸Fredericksburg, Virginia, United States
Denver Infectious Diseases Consultants CRS
🇺🇸Denver, Colorado, United States
Eastside Family Health Ctr. CRS
🇺🇸Denver, Colorado, United States
Legacy Clinic Good Samaritan CRS
🇺🇸Portland, Oregon, United States
Kaiser Permanente of Denver CRS
🇺🇸Denver, Colorado, United States
Univ. of Colorado Health Science Ctr. CRS
🇺🇸Denver, Colorado, United States
Denver Public Health CRS - INSIGHT
🇺🇸Denver, Colorado, United States
Denver Public Health CRS
🇺🇸Denver, Colorado, United States
Multnomah County Health Dept., HIV Health Services Ctr. CRS
🇺🇸Portland, Oregon, United States
Denver VAMC CRS
🇺🇸Denver, Colorado, United States
The Research & Education Group-Portland CRS
🇺🇸Portland, Oregon, United States
Kaiser Immune Deficiency Clinic of Portland CRS
🇺🇸Portland, Oregon, United States
Legacy Clinic Emanuel CRS
🇺🇸Portland, Oregon, United States
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
🇺🇸Portland, Oregon, United States
Hanover Med. Park (Mechanicsville, VA) CRS
🇺🇸Mechanicsville, Virginia, United States
Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS
🇺🇸Norfolk, Virginia, United States
Petersburg Health Care Alliance CRS
🇺🇸Petersburg, Virginia, United States
East Bay AIDS Ctr. CRS
🇺🇸Oakland, California, United States
Beacon Clinic at Boulder CRS
🇺🇸Boulder, Colorado, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
🇺🇸Washington, District of Columbia, United States
Cooper Hospital/Univ. Med. Ctr., The Cooper Early Intervention Program (EIP) CRS
🇺🇸Camden, New Jersey, United States
Atlanta VAMC CRS
🇺🇸Decatur, Georgia, United States
McAuley Health Ctr. CRS
🇺🇸Grand Rapids, Michigan, United States
New Jersey Medical School- Adult Clinical Research Ctr. CRS
🇺🇸Newark, New Jersey, United States
South Jersey Infectious Disease, Cape Clinical Trials CRS
🇺🇸Somers Point, New Jersey, United States
St. Vincent Hosp. & Med. Ctr. CRS
🇺🇸New York, New York, United States
Bronx Prevention Center CRS
🇺🇸Bronx, New York, United States
Wayne State Univ. CRS
🇺🇸Detroit, Michigan, United States
Wayne State Univ. INSIGHT CRS
🇺🇸Detroit, Michigan, United States
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
🇺🇸Portland, Oregon, United States
Cooper Univ. Hosp. CRS
🇺🇸Camden, New Jersey, United States
The Early Intervention Program at Kennedy Hosp. CRS
🇺🇸Voorhees, New Jersey, United States
Vernon Harris East End Community Health Ctr. CRS
🇺🇸Richmond, Virginia, United States
CrossOver Health Ctr. CRS
🇺🇸Richmond, Virginia, United States
South Richmond Health Care Ctr. CRS
🇺🇸Richmond, Virginia, United States
Hunter Holmes McGuire VAMC CRS
🇺🇸Richmond, Virginia, United States
VCU Health Systems, Infectious Disease Clinic CRS
🇺🇸Richmond, Virginia, United States
AIDS Healthcare Foundation CRS
🇺🇸Beverly Hills, California, United States