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

HIV Transmission Risk Behavior Substudy

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Delayed ART; Drug: Continuous ART

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.

• Study Type: Observational
• Enrollment (Actual): 883

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • AIDS Healthcare Foundation CRS
    • Fresno, California, United States, 93702
      • UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS
    • Mill Valley, California, United States, 94941-3013
      • Dr. M. Estes Med. Practice CRS
    • Oakland, California, United States, 94609
      • Dr. Robert Scott Med. Practice CRS
    • Oakland, California, United States, 94609
      • East Bay AIDS Ctr. CRS
    • San Francisco, California, United States, 94114
      • Castro-Mission Health Ctr. CRS
    • San Francisco, California, United States, 94102
      • Dr. Shawn Hassler Med. Practice CRS
    • San Francisco, California, United States, 94110
      • Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
    • San Francisco, California, United States, 94114-1010
      • Dr. Virginia Cafaro Med. Practice CRS
    • San Francisco, California, United States, 94114-1010
      • Dr. William Owen Med. Practice CRS
    • San Francisco, California, United States, 94121
      • San Francisco VAMC, Infectious Diseases Clinic CRS
    • San Francisco, California, United States, 94143
      • UCSF PHP, Gen. Internal Medicine Practice CRS
  • Colorado
    • Boulder, Colorado, United States, 80501-4507
      • Beacon Clinic at Boulder CRS
    • Denver, Colorado, United States, 80204-4507
      • Univ. of Colorado Health Science Ctr. CRS
    • Denver, Colorado, United States, 80205
      • Eastside Family Health Ctr. CRS
    • Denver, Colorado, United States, 80204
      • Denver Public Health CRS
    • Denver, Colorado, United States, 80204-4507
      • Denver Infectious Diseases Consultants CRS
    • Denver, Colorado, United States, 80204-4507
      • Kaiser Permanente of Denver CRS
    • Denver, Colorado, United States, 80204
      • Denver Public Health CRS - INSIGHT
    • Denver, Colorado, United States, 80220
      • Denver VAMC CRS
    • Wheat Ridge, Colorado, United States, 80033
      • Western Infectious Disease Consultants CRS
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
  • Florida
    • Miami, Florida, United States, 33125
      • Miami VAMC CRS
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta VAMC CRS
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State Univ. CRS
    • Detroit, Michigan, United States, 48201
      • Harper Hosp., Detroit CRS
    • Detroit, Michigan, United States, 48201
      • Wayne State Univ. INSIGHT CRS
    • Detroit, Michigan, United States, 48215
      • Detroit Community Health Connection, Inc. CRS
    • Grand Rapids, Michigan, United States, 49503
      • McAuley Health Ctr. CRS
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Univ. Hosp. CRS
    • Camden, New Jersey, United States
      • Cooper Hospital/Univ. Med. Ctr., The Cooper Early Intervention Program (EIP) CRS
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School- Adult Clinical Research Ctr. CRS
    • Somers Point, New Jersey, United States, 08244
      • South Jersey Infectious Disease, Cape Clinical Trials CRS
    • Voorhees, New Jersey, United States, 08043
      • The Early Intervention Program at Kennedy Hosp. CRS
  • New York
    • Bronx, New York, United States, 10457
      • Bronx-Lebanon Hosp. Ctr. CRS
    • Bronx, New York, United States, 10452
      • Bronx Prevention Center CRS
    • Bronx, New York, United States, 10467
      • Montefiore Med. Ctr., AIDS Ctr. CRS
    • New York, New York, United States, 10011
      • St. Vincent Hosp. & Med. Ctr. CRS
  • Oregon
    • Eugene, Oregon, United States, 97401
      • PeaceHealth Med. Group - Hilyard Street Clinic CRS
    • Portland, Oregon, United States, 97227
      • Kaiser Immune Deficiency Clinic of Portland CRS
    • Portland, Oregon, United States, 97239
      • Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
    • Portland, Oregon, United States, 97210
      • The Research & Education Group-Portland CRS
    • Portland, Oregon, United States, 97204
      • Multnomah County Health Dept., HIV Health Services Ctr. CRS
    • Portland, Oregon, United States, 97210
      • Legacy Clinic Good Samaritan CRS
    • Portland, Oregon, United States, 97213
      • Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
    • Portland, Oregon, United States, 97227
      • Legacy Clinic Emanuel CRS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple Univ. School of Medicine CRS
    • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia FIGHT - Dr. Jay Kostman CRS
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Med. Ctr., Immunodeficiency Ctr. CRS
  • Virginia
    • Fredericksburg, Virginia, United States, 22401
      • MediCorp, Infectious Disease Associates CRS
    • Mechanicsville, Virginia, United States, 23116
      • Hanover Med. Park (Mechanicsville, VA) CRS
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS
    • Petersburg, Virginia, United States, 23803
      • Petersburg Health Care Alliance CRS
    • Richmond, Virginia, United States, 23224
      • CrossOver Health Ctr. CRS
    • Richmond, Virginia, United States, 23224
      • South Richmond Health Care Ctr. CRS
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VAMC CRS
    • Richmond, Virginia, United States, 23298
      • VCU Health Systems, Infectious Disease Clinic CRS
    • Richmond, Virginia, United States, 23223
      • Vernon Harris East End Community Health Ctr. CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV infected participants with a CD4+ cell count greater than 350 cells/mm3 currently receiving or not receiving ART.

Description

Inclusion Criteria:

• Coenrollment in the SMART study
• Parent or guardian willing to provide informed consent, if applicable

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
2: VS Group; HIV infected participants who continue ART to keep viral loads as low as possible, regardless of CD4 cell count.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the DC group to the VS group for HIV transmission and risk behaviors	At the end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
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
To develop analytic techniques to combine behavioral and biological data into a measure of overall transmission risk	At the end of study

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Community Programs for Clinical Research on AIDS
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Click here for more information on CPCRA 065

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 6, 2006
• First Submitted That Met QC Criteria: October 6, 2006
• First Posted (Estimate): October 11, 2006

Study Record Updates

• Last Update Posted (Estimate): April 17, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Treatment Experienced
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: CPCRA 065B; SMART; 10113 (Registry Identifier: DAIDS-ES)