#H AND M AD WITH TRANSGENDER MANUAL#
Section 14: Computer Assisted Self-Interview (CASI)Īppendix IIA: HPTN 083 Record of Dispensation of Participant-Specific Study Product to Non-Pharmacy StaffĪppendix IIB: HPTN 083 Record of Return of Participant-Specific Study Product by Non-Pharmacy StaffĪppendix III: Schedule of Forms and CASI SurveysĪppendix IV: Participant Transfer and Receipt Process within Medidata RaveĪppendix V: Guidance for the Management of “Discordant/discrepant” HIV Testing Results – HPTN 083 and 084Īppendix VI: Emergency Unblinding by CRS IoR for Medical ReasonsĪppendix VII: SSP Manual Updates Per LoA #1 to Version 3.0 of the ProtocolĪppendix VIII: SSP Manual Updates Per Version 5.0 of the Protocol Section 11: Laboratory and Specimen Management Procedures Section 10: Adverse Event Reporting and Safety Monitoring Section 4: Recruitment, Screening, and Enrollment HPTN 083 Study-Specific Procedures Manual Overview and Version Control
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The hazard ratio for the CAB versus TDF/FTC arms is 0.34 (95% CI 0.18-0.62), corresponding to a 66% reduction in incident HIV infections in study participants given CAB compared to TDF/FTC. A total of 52 incident HIV infections occurred, with 13 incident infections in the CAB arm (incidence rate 0.41%) and 39 incident infections in the TDF/FTC arm (incidence rate 1.22%). National Institute of Allergy and Infectious Diseases (NIAID), approved the decision to stop the blinded part of the study.Īfter a more extensive analysis of the interim study data, the regimen containing CAB LA was found to be statistically superior to daily oral TDF/FTC for PrEP among the cisgender men and transgender women who have sex with men enrolled in HPTN 083. A total of 50 incident HIV infections occurred in HPTN 083, with 38 incident HIV infections in the TDF/FTC arm (incidence rate 1.21%) and 12 incident HIV infections in the CAB arm (incidence rate 0.38%): in other words, approximately three times the number of incident HIV infections were in the TDF/FTC arm than in the CAB arm.
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The study results showed that CAB LA, administered every eight weeks, provided high efficacy compared to TDF/FTC. On a Data and Safety Monitoring Board (DSMB) reviewed HPTN 083 study data and recommended that the blinded part of the study be stopped early for successfully meeting its specified objectives.
#H AND M AD WITH TRANSGENDER PLUS#
Participants were randomized to one of two study arms and included three steps: Step 1 consisted of 5 weeks of daily oral CAB and a TDF/FTC placebo or 5 weeks of daily oral TDF/FTC and an oral CAB placebo Step 2 consisted of 148 weeks of intramuscular CAB LA 600 mg every 8 weeks plus daily oral TDF/FTC placebo or 148 weeks of daily oral TDF/FTC plus an intramuscular CAB LA placebo every 8 weeks and Step 3 consisted of an open-label daily oral TDF/FTC for 48 weeks after participants completed Step 2. Participants in each group received both injections and oral tablets – each participant received one active drug and one placebo (no active drug) in order to maintain the blinded nature of the study. Neither the participants nor the study team knows who was in which group. Participants were assigned randomly (by chance) to either the CAB or oral TDF/FTC group. Some people also may find periodic injections to be a more discreet form of HIV PrEP than daily pills and may prefer CAB LA for that reason. The development of safe and effective long acting alternative agents for HIV PrEP would increase HIV prevention choices and help those who find taking a daily pill challenging. Why is HPTN 083 important?įor many people, taking a daily pill can be challenging. HPTN 083 enrolled 4,570 cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men at 43 sites in Argentina, Brazil, Peru, United States, South Africa, Thailand and Vietnam. HPTN 083 is the first study to compare the efficacy of CAB LA to daily oral TDF/FTC for HIV PrEP.
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Press Release Press Coverage July 16 Public Webinar *** 7 July 2020 *** HPTN 083 Study Demonstrates Superiority of Cabotegravir for the Prevention of HIV Laboratory Paper, The Journal of Infectious Diseases, Aug 12, 2021
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