Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386035
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2006-10-06
Brief Title:
Effects of Two Anti-HIV Drug Regimens on HIV Transmission Risk Behavior Among SMART Study Participants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HIV Transmission Risk Behavior Substudy
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 1000 copiesml 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 cellsmm3 will be initiated until CD4 cell count is at least 350 cellsmm3 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
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 cellsmm3 will be initiated until CD4 cell count is at least 350 cellsmm3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10113 | REGISTRY | DAIDS-ES | None |
| SMART | None | None | None |