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NCT00386035 Clinical Trial

Effects of Two Anti-HIV Drug Regimens on HIV Transmission Risk Behavior Among SMART Study Participants

HIV Infections Clinical Trial

Official title:
HIV Transmission Risk Behavior Substudy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00386035
Other study ID # CPCRA 065B
Secondary ID SMART10113
Status Completed
Phase N/A
First received October 6, 2006
Last updated April 15, 2014
Start date January 2002
Est. completion date September 2008

Study information
Verified date April 2014
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 883
Est. completion date September 2008
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- Coenrollment in the SMART study

- Parent or guardian willing to provide informed consent, if applicable

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

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

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Community Programs for Clinical Research on AIDS

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Remien RH, Halkitis PN, O'Leary A, Wolitski RJ, Gómez CA. Risk Perception and sexual risk behaviors among HIV-positive men on antiretroviral therapy. AIDS Behav. 2005 Jun;9(2):167-76. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the DC group to the VS group for HIV transmission and risk behaviors At the end of study No
Secondary 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 No
Secondary 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 Yes
Secondary To evaluate the correlation between self-reported adherence to ART and HIV transmission risk behavior for participants on ART At the end of study No
Secondary 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 No
Secondary 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 No
Secondary To develop analytic techniques to combine behavioral and biological data into a measure of overall transmission risk At the end of study No
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