Effects of Two Anti-HIV Drug Regimens on HIV Transmission Risk Behavior Among SMART Study Participants
NCT ID: NCT00386035
Last Updated: 2014-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
883 participants
OBSERVATIONAL
2002-01-31
2008-09-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1: DC Group
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.
Delayed ART
Participants follow a drug conservation (DC) regimen in which ART is stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count is at least 350 cells/mm3, and then are followed by episodic ART based on CD4 cell count.
2: VS Group
HIV infected participants who continue ART to keep viral loads as low as possible, regardless of CD4 cell count.
Continuous ART
Group 2 participants follow a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count.
Interventions
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Delayed ART
Participants follow a drug conservation (DC) regimen in which ART is stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count is at least 350 cells/mm3, and then are followed by episodic ART based on CD4 cell count.
Continuous ART
Group 2 participants follow a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count.
Eligibility Criteria
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Inclusion Criteria
* Parent or guardian willing to provide informed consent, if applicable
13 Years
ALL
No
Sponsors
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Community Programs for Clinical Research on AIDS
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Wafaa El-Sadr, MD, MPH
Role: STUDY_CHAIR
Harlem AIDS Treatment Group, Harlem Hospital Center
James Neaton, PhD
Role: STUDY_CHAIR
CPCRA Statistical and Data Management Center/CCBR
Locations
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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
San Francisco VAMC, Infectious Diseases Clinic CRS
San Francisco, California, United States
UCSF PHP, Gen. Internal Medicine Practice CRS
San Francisco, California, United States
Beacon Clinic at Boulder CRS
Boulder, Colorado, United States
Denver Infectious Diseases Consultants CRS
Denver, Colorado, 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
Eastside Family Health Ctr. CRS
Denver, Colorado, United States
Denver VAMC CRS
Denver, Colorado, United States
Western Infectious Disease Consultants CRS
Wheat Ridge, Colorado, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, United States
Miami VAMC CRS
Miami, Florida, United States
Atlanta VAMC CRS
Decatur, Georgia, United States
Harper Hosp., Detroit CRS
Detroit, Michigan, United States
Wayne State Univ. CRS
Detroit, Michigan, United States
Wayne State Univ. INSIGHT CRS
Detroit, Michigan, United States
Detroit Community Health Connection, Inc. CRS
Detroit, Michigan, United States
McAuley Health Ctr. CRS
Grand Rapids, Michigan, United States
Cooper Univ. Hosp. CRS
Camden, New Jersey, United States
Cooper Hospital/Univ. Med. Ctr., The Cooper Early Intervention Program (EIP) CRS
Camden, New Jersey, 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
The Early Intervention Program at Kennedy Hosp. CRS
Voorhees Township, New Jersey, United States
St. Vincent Hosp. & Med. Ctr. CRS
New York, New York, United States
Bronx Prevention Center CRS
The Bronx, New York, United States
Bronx-Lebanon Hosp. Ctr. CRS
The Bronx, New York, United States
Montefiore Med. Ctr., AIDS Ctr. CRS
The Bronx, New York, United States
PeaceHealth Med. Group - Hilyard Street Clinic CRS
Eugene, Oregon, United States
Multnomah County Health Dept., HIV Health Services Ctr. CRS
Portland, Oregon, United States
Legacy Clinic Good Samaritan CRS
Portland, Oregon, United States
The Research & Education Group-Portland CRS
Portland, Oregon, United States
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. 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
Philadelphia FIGHT - Dr. Jay Kostman CRS
Philadelphia, Pennsylvania, United States
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, United States
Albert Einstein Med. Ctr., Immunodeficiency Ctr. CRS
Philadelphia, Pennsylvania, United States
MediCorp, Infectious Disease Associates CRS
Fredericksburg, Virginia, 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
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
Countries
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References
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Bunnell R, Ekwaru JP, Solberg P, Wamai N, Bikaako-Kajura W, Were W, Coutinho A, Liechty C, Madraa E, Rutherford G, Mermin J. Changes in sexual behavior and risk of HIV transmission after antiretroviral therapy and prevention interventions in rural Uganda. AIDS. 2006 Jan 2;20(1):85-92. doi: 10.1097/01.aids.0000196566.40702.28.
Kozal MJ, Amico KR, Chiarella J, Schreibman T, Cornman D, Fisher W, Fisher J, Friedland G. Antiretroviral resistance and high-risk transmission behavior among HIV-positive patients in clinical care. AIDS. 2004 Nov 5;18(16):2185-9. doi: 10.1097/00002030-200411050-00011.
Remien RH, Halkitis PN, O'Leary A, Wolitski RJ, Gomez CA. Risk Perception and sexual risk behaviors among HIV-positive men on antiretroviral therapy. AIDS Behav. 2005 Jun;9(2):167-76. doi: 10.1007/s10461-005-3898-7.
Related Links
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Click here for more information on CPCRA 065
Other Identifiers
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SMART
Identifier Type: -
Identifier Source: secondary_id
10113
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 065B
Identifier Type: -
Identifier Source: org_study_id
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