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

This study has been completed.
Sponsor:
Collaborator:
Community Programs for Clinical Research on AIDS
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00386035
First received: October 6, 2006
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Delayed ART
Drug: Continuous ART

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV Transmission Risk Behavior Substudy

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • To compare the DC group to the VS group for HIV transmission and risk behaviors [ Time Frame: At the end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the VS group to the DC group on HIV transmission risk behavior in participants who are not on ART at enrollment [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At the end of study ] [ Designated as safety issue: Yes ]
  • To evaluate the correlation between self-reported adherence to ART and HIV transmission risk behavior for participants on ART [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
  • To evaluate the correlation between self-reported transmission risk behavior and the acquisition of certain sexually transmitted diseases as specified in the protocol. [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
  • To develop analytic techniques to combine behavioral and biological data into a measure of overall transmission risk [ Time Frame: At the end of study ] [ Designated as safety issue: No ]

Enrollment: 883
Study Start Date: January 2002
Study Completion Date: September 2008
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Coenrollment in the SMART study
  • Parent or guardian willing to provide informed consent, if applicable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386035

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

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00386035     History of Changes
Other Study ID Numbers: CPCRA 065B, SMART, 10113
Study First Received: October 6, 2006
Last Updated: April 15, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014