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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Delayed ART; Drug: Continuous ART

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00386035

SMART

10113 (Registry Identifier)

CPCRA 065B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 883 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

883 participants in 2 patient groups

1: DC Group

Description:

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.

Treatment:

Drug: Delayed ART

2: VS Group

Description:

HIV infected participants who continue ART to keep viral loads as low as possible, regardless of CD4 cell count.

Treatment:

Drug: Continuous ART