HPTN 052
A Randomized Trial to Evaluate the Effectiveness of
Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone
to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
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Study Oversight
Several committees provide
oversight and review of HPTN 052. This website provides
information regarding the membership and activities of these committees.
- Clinical Management Committee (CMC)
- The CMC is responsible for answering
clinically-related questions. Questions to this committee can
include, but are not limited to:
- Questions about inclusion and
exclusion criteria for particular participants
- Questions about protocol
interpretation
- Questions about ART management
(e.g., regimen change or toxicity management)
- Questions about primary HIV care
- Questions about the clinical
management of co-morbidities
- Questions about the prophylaxis
and treatment of OIs
- Questions about AE management
- Questions about grading and
reporting AEs and EAEs
- Clinically-related questions may be
submitted to the CMC by sending email to
052CMC@HPTN.org
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CMC Roster
-
CMC Schedule
(November
2009 - June 2010) (Effective 8 Feb 2010)
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CMC Questions and Answers
- Protocol Safety Review Team (PSRT)
- The PSRT conducts regular reviews of standardized study safety data
reports and relays any identified safety concerns to the DAIDS Vaccine
and Prevention Data and Safety Monitory Board.
- Safety Monitoring Committee (SMC)
- SMC Reports
- SMC Recommendations/Minutes
- Data Safety Monitoring Board (DSMB)
- DSMB Open Reports
- DSMB Recommendations/Minutes
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