AzTrials
AzTrials

HIV InfectionsNCT00386035

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

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
What is being tested?
Delayed ART and Continuous ART
How many people
883 participants
Where
58 sitesUnited States
Study dates
Jan 2002to Sep 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • AIDS Healthcare Foundation CRS

    Beverly Hills, California, 90211

  • Beacon Clinic at Boulder CRS

    Boulder, Colorado, 80501-4507

  • Cooper Univ. Hosp. CRS

    Camden, New Jersey, 08103

  • Cooper Hospital/Univ. Med. Ctr., The Cooper Early Intervention Program (EIP) CRS

    Camden, New Jersey

  • Atlanta VAMC CRS

    Decatur, Georgia, 30033

  • Denver Infectious Diseases Consultants CRS

    Denver, Colorado, 80204-4507

  • Kaiser Permanente of Denver CRS

    Denver, Colorado, 80204-4507

  • Univ. of Colorado Health Science Ctr. CRS

    Denver, Colorado, 80204-4507

  • Denver Public Health CRS - INSIGHT

    Denver, Colorado, 80204

  • Denver Public Health CRS

    Denver, Colorado, 80204

  • Eastside Family Health Ctr. CRS

    Denver, Colorado, 80205

  • Denver VAMC CRS

    Denver, Colorado, 80220

  • Harper Hosp., Detroit CRS

    Detroit, Michigan, 48201

  • Wayne State Univ. CRS

    Detroit, Michigan, 48201

  • Wayne State Univ. INSIGHT CRS

    Detroit, Michigan, 48201

  • Detroit Community Health Connection, Inc. CRS

    Detroit, Michigan, 48215

  • PeaceHealth Med. Group - Hilyard Street Clinic CRS

    Eugene, Oregon, 97401

  • MediCorp, Infectious Disease Associates CRS

    Fredericksburg, Virginia, 22401

  • UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS

    Fresno, California, 93702

  • McAuley Health Ctr. CRS

    Grand Rapids, Michigan, 49503

  • Hanover Med. Park (Mechanicsville, VA) CRS

    Mechanicsville, Virginia, 23116

  • Miami VAMC CRS

    Miami, Florida, 33125

  • Dr. M. Estes Med. Practice CRS

    Mill Valley, California, 94941-3013

  • St. Vincent Hosp. & Med. Ctr. CRS

    New York, New York, 10011

  • New Jersey Medical School- Adult Clinical Research Ctr. CRS

    Newark, New Jersey, 07103

  • Eastern Virginia Med. School, Ctr. for the Comprehensive Care of Immune Deficiency CRS

    Norfolk, Virginia, 23507

  • Dr. Robert Scott Med. Practice CRS

    Oakland, California, 94609

  • East Bay AIDS Ctr. CRS

    Oakland, California, 94609

  • Petersburg Health Care Alliance CRS

    Petersburg, Virginia, 23803

  • Philadelphia FIGHT - Dr. Jay Kostman CRS

    Philadelphia, Pennsylvania, 19107

  • Temple Univ. School of Medicine CRS

    Philadelphia, Pennsylvania, 19140

  • Albert Einstein Med. Ctr., Immunodeficiency Ctr. CRS

    Philadelphia, Pennsylvania, 19141

  • Multnomah County Health Dept., HIV Health Services Ctr. CRS

    Portland, Oregon, 97204

  • Legacy Clinic Good Samaritan CRS

    Portland, Oregon, 97210

  • The Research & Education Group-Portland CRS

    Portland, Oregon, 97210

  • Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS

    Portland, Oregon, 97213

  • Kaiser Immune Deficiency Clinic of Portland CRS

    Portland, Oregon, 97227

  • Legacy Clinic Emanuel CRS

    Portland, Oregon, 97227

  • Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS

    Portland, Oregon, 97239

  • Vernon Harris East End Community Health Ctr. CRS

    Richmond, Virginia, 23223

  • CrossOver Health Ctr. CRS

    Richmond, Virginia, 23224

  • South Richmond Health Care Ctr. CRS

    Richmond, Virginia, 23224

  • Hunter Holmes McGuire VAMC CRS

    Richmond, Virginia, 23249

  • VCU Health Systems, Infectious Disease Clinic CRS

    Richmond, Virginia, 23298

  • Dr. Shawn Hassler Med. Practice CRS

    San Francisco, California, 94102

  • Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS

    San Francisco, California, 94110

  • Dr. Virginia Cafaro Med. Practice CRS

    San Francisco, California, 94114-1010

  • Dr. William Owen Med. Practice CRS

    San Francisco, California, 94114-1010

  • Castro-Mission Health Ctr. CRS

    San Francisco, California, 94114

  • San Francisco VAMC, Infectious Diseases Clinic CRS

    San Francisco, California, 94121

  • UCSF PHP, Gen. Internal Medicine Practice CRS

    San Francisco, California, 94143

  • South Jersey Infectious Disease, Cape Clinical Trials CRS

    Somers Point, New Jersey, 08244

  • Bronx Prevention Center CRS

    The Bronx, New York, 10452

  • Bronx-Lebanon Hosp. Ctr. CRS

    The Bronx, New York, 10457

  • Montefiore Med. Ctr., AIDS Ctr. CRS

    The Bronx, New York, 10467

  • The Early Intervention Program at Kennedy Hosp. CRS

    Voorhees Township, New Jersey, 08043

  • Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

    Washington D.C., District of Columbia, 20422

  • Western Infectious Disease Consultants CRS

    Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
HIV Infections
Being tested
Delayed ART, Continuous ART
Keywords
Treatment Experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delayed ARTDrug

    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 ARTDrug

    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.

Study groups in NCT00386035
Study groupRoleWhat they receive
1: DC GroupHIV 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.
Receives: Drug: Delayed ART
2: VS GroupHIV infected participants who continue ART to keep viral loads as low as possible, regardless of CD4 cell count.
Receives: Drug: Continuous ART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the DC group to the VS group for HIV transmission and risk behaviors

    Measured: At the end of study

Secondary outcomes (6)

  1. To compare the VS group to the DC group on HIV transmission risk behavior in participants who are not on ART at enrollment

    Measured: At the end of study

  2. 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

    Measured: At the end of study

  3. To evaluate the correlation between self-reported adherence to ART and HIV transmission risk behavior for participants on ART

    Measured: At the end of study

  4. 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.

    Measured: At the end of study

  5. To evaluate the correlation between self-reported transmission risk behavior and the acquisition of certain sexually transmitted diseases as specified in the protocol.

    Measured: At the end of study

  6. To develop analytic techniques to combine behavioral and biological data into a measure of overall transmission risk

    Measured: At the end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2006 (estimated)
  2. Study startJan 2002
  3. Primary completionJan 2006
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
883 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00386035
Sponsor's protocol ID
CPCRA 065B
Other IDs
SMART, 10113
Status last verified
Apr 2014
First submitted
6 Oct 2006
Last updated
17 Apr 2014
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 16327323

  • 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.

    PubMed 15577652

  • 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.

    PubMed 15933836

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the DC group to the VS group for HIV transmission and risk behaviors (time frame: At the end of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00386035, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in