Effects of Two Anti-HIV Drug Regimens on HIV Transmission Risk Behavior Among SMART Study Participants
HIV Transmission Risk Behavior Substudy
3 other identifiers
observational
883
1 country
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2002
Longer than P75 for all trials
58 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
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 6, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedApril 17, 2014
April 1, 2014
4 years
October 6, 2006
April 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the DC group to the VS group for HIV transmission and risk behaviors
At the end of study
Secondary Outcomes (6)
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
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 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
- +1 more secondary outcomes
Study Arms (2)
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.
2: VS Group
HIV infected participants who continue ART to keep viral loads as low as possible, regardless of CD4 cell count.
Interventions
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.
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
HIV infected participants with a CD4+ cell count greater than 350 cells/mm3 currently receiving or not receiving ART.
You may qualify if:
- Coenrollment in the SMART study
- Parent or guardian willing to provide informed consent, if applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
AIDS Healthcare Foundation CRS
Beverly Hills, California, 90211, United States
UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS
Fresno, California, 93702, United States
Dr. M. Estes Med. Practice CRS
Mill Valley, California, 94941-3013, United States
Dr. Robert Scott Med. Practice CRS
Oakland, California, 94609, United States
East Bay AIDS Ctr. CRS
Oakland, California, 94609, United States
Dr. Shawn Hassler Med. Practice CRS
San Francisco, California, 94102, United States
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
San Francisco, California, 94110, United States
Dr. Virginia Cafaro Med. Practice CRS
San Francisco, California, 94114-1010, United States
Dr. William Owen Med. Practice CRS
San Francisco, California, 94114-1010, United States
Castro-Mission Health Ctr. CRS
San Francisco, California, 94114, United States
San Francisco VAMC, Infectious Diseases Clinic CRS
San Francisco, California, 94121, United States
UCSF PHP, Gen. Internal Medicine Practice CRS
San Francisco, California, 94143, United States
Beacon Clinic at Boulder CRS
Boulder, Colorado, 80501-4507, United States
Denver Infectious Diseases Consultants CRS
Denver, Colorado, 80204-4507, United States
Kaiser Permanente of Denver CRS
Denver, Colorado, 80204-4507, United States
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, 80204-4507, United States
Denver Public Health CRS - INSIGHT
Denver, Colorado, 80204, United States
Denver Public Health CRS
Denver, Colorado, 80204, United States
Eastside Family Health Ctr. CRS
Denver, Colorado, 80205, United States
Denver VAMC CRS
Denver, Colorado, 80220, United States
Western Infectious Disease Consultants CRS
Wheat Ridge, Colorado, 80033, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, 20422, United States
Miami VAMC CRS
Miami, Florida, 33125, United States
Atlanta VAMC CRS
Decatur, Georgia, 30033, United States
Harper Hosp., Detroit CRS
Detroit, Michigan, 48201, United States
Wayne State Univ. CRS
Detroit, Michigan, 48201, United States
Wayne State Univ. INSIGHT CRS
Detroit, Michigan, 48201, United States
Detroit Community Health Connection, Inc. CRS
Detroit, Michigan, 48215, United States
McAuley Health Ctr. CRS
Grand Rapids, Michigan, 49503, United States
Cooper Univ. Hosp. CRS
Camden, New Jersey, 08103, 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, 07103, United States
South Jersey Infectious Disease, Cape Clinical Trials CRS
Somers Point, New Jersey, 08244, United States
The Early Intervention Program at Kennedy Hosp. CRS
Voorhees Township, New Jersey, 08043, United States
St. Vincent Hosp. & Med. Ctr. CRS
New York, New York, 10011, United States
Bronx Prevention Center CRS
The Bronx, New York, 10452, United States
Bronx-Lebanon Hosp. Ctr. CRS
The Bronx, New York, 10457, United States
Montefiore Med. Ctr., AIDS Ctr. CRS
The Bronx, New York, 10467, United States
PeaceHealth Med. Group - Hilyard Street Clinic CRS
Eugene, Oregon, 97401, United States
Multnomah County Health Dept., HIV Health Services Ctr. CRS
Portland, Oregon, 97204, United States
Legacy Clinic Good Samaritan CRS
Portland, Oregon, 97210, United States
The Research & Education Group-Portland CRS
Portland, Oregon, 97210, United States
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
Portland, Oregon, 97213, United States
Kaiser Immune Deficiency Clinic of Portland CRS
Portland, Oregon, 97227, United States
Legacy Clinic Emanuel CRS
Portland, Oregon, 97227, United States
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
Portland, Oregon, 97239, United States
Philadelphia FIGHT - Dr. Jay Kostman CRS
Philadelphia, Pennsylvania, 19107, United States
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, 19140, United States
Albert Einstein Med. Ctr., Immunodeficiency Ctr. CRS
Philadelphia, Pennsylvania, 19141, United States
MediCorp, Infectious Disease Associates CRS
Fredericksburg, Virginia, 22401, United States
Hanover Med. Park (Mechanicsville, VA) CRS
Mechanicsville, Virginia, 23116, United States
Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS
Norfolk, Virginia, 23507, United States
Petersburg Health Care Alliance CRS
Petersburg, Virginia, 23803, United States
Vernon Harris East End Community Health Ctr. CRS
Richmond, Virginia, 23223, United States
CrossOver Health Ctr. CRS
Richmond, Virginia, 23224, United States
South Richmond Health Care Ctr. CRS
Richmond, Virginia, 23224, United States
Hunter Holmes McGuire VAMC CRS
Richmond, Virginia, 23249, United States
VCU Health Systems, Infectious Disease Clinic CRS
Richmond, Virginia, 23298, United States
Related Publications (3)
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.
PMID: 16327323BACKGROUNDKozal 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.
PMID: 15577652BACKGROUNDRemien 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.
PMID: 15933836BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wafaa El-Sadr, MD, MPH
Harlem AIDS Treatment Group, Harlem Hospital Center
- STUDY CHAIR
James Neaton, PhD
CPCRA Statistical and Data Management Center/CCBR
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2006
First Posted
October 11, 2006
Study Start
January 1, 2002
Primary Completion
January 1, 2006
Study Completion
September 1, 2008
Last Updated
April 17, 2014
Record last verified: 2014-04