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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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HIV Transmission Risk Behavior Substudy

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Delayed ART
* Drug: Continuous ART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coenrollment in the SMART study Parent or guardian willing to provide informed consent, if applicable

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1: DC Group<br>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<br>* 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.<br>|
| 2: VS Group<br>HIV infected participants who continue ART to keep viral loads as low as possible, regardless of CD4 cell count. | Drug: Continuous ART<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced