A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women.
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What is HPTN 084?
HPTN 084 (The LIFE Study) is a study being done to evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.
Who is participating in the study?
HPTN 084 will enroll approximately 3,200 women 18 to 45 years old in sub-Saharan Africa who are at risk for acquiring HIV.
Why is HPTN 084 important?
PrEP agents are needed that do not depend on daily or near-daily pill-taking. The development of alternative agents for PrEP, and/or more adherence-friendly schedules for currently available agents, could increase prevention choices and increase acceptability. Long-acting injectable agents have the potential to prevent HIV acquisition without relying on adherence to a daily oral regimen.
What happens during the study?
Once randomized to one of two arms, participants move through the steps below and are followed for up to 4 and a half years (active drugs are shown in bold text):
Arm A – Daily oral CAB (30 mg tablets) and oral TDF/FTC placebo for five weeks plus an HIV prevention package including behavioral risk reduction and adherence counseling, provision of condoms.
Arm B – Daily oral TDF/FTC (300 mg/200 mg fixed-dose combination tablets) and oral CAB placebo for five weeks plus an HIV prevention package including behavioral risk reduction and adherence counseling, provision of condoms.
A participant that becomes HIV-infected during Step 1 of the study will permanently discontinue study product and will be terminated from the study, and referred for HIV-related care.
Arm A – CAB LA (600 mg as a single intramuscular [IM] injection at two time points 4 weeks apart and every 8 weeks thereafter) and daily oral TDF/FTC placebo plus an HIV prevention package including behavioral risk reduction and adherence counseling, provision of condoms.
Arm B – Daily oral TDF/FTC (300/200 mg fixed-dose combination tablets) and IM placebo at two time points 4 weeks apart and every 8 weeks thereafter (matching vehicle, identical volume as active injectable product in Arm A) plus an HIV prevention package including behavioral risk reduction and adherence counseling, provision of condoms.
This step will continue until the required number of endpoints (111) is reached, estimated to be 81 weeks after enrolling the last participant.
A participant that becomes HIV-infected during Step 2 of the study will permanently discontinue study product, be placed on immediate suppressive ART, and be followed for 52 weeks after their last injection, after which their participation in the study will end and they will be transitioned to continued HIV-related care.
Arms A and B – Open-label daily TDF/FTC (in order to cover the pharmacokinetic [PK] tail for Arm A participants) will be provided no later than eight weeks after the last injection visit, for up to 48 weeks plus an HIV prevention package including behavioral risk reduction and adherence counseling, and provision of condoms. Participants will then transition to locally available HIV prevention services, including services for PrEP, if available.
A participant with confirmed HIV infection during Step 3 will be followed at least for the duration of Step 3.
HPTN 084 Version 2.0
- HPTN 084 Protocol V2.0 - 6 November 2019
- HPTN 084 Summary of Changes from V1.0 to V2.0 - 6 November 2019
- HPTN 084 CM #1 - 22 January 2020
HPTN 084 Version 1.0
- HPTN 084 Protocol V1.0 - 2 March 2017
- HPTN 084 LoA #1 - 15 August 2017
- HPTN 084 LoA #2 - 24 January 2018
- HPTN 084 LoA #3 - 31 May 2018
- HPTN 084 CM #1 - 11 May 2017
- HPTN 084 CM #2 - 26 Sept. 2017
- HPTN 084 CM #3 - 2 August 2019
- HPTN 084 FAQ - Updated July 2020
- Tips and Lessons Learned - Updated April 2020
- The Similarities and Differences Between HPTN 083 and HPTN 084 - July 2020
- HIV Prevention Trials Network (HPTN) Announces Initiation of HPTN 084: First Large-Scale Study in Women of a Long-Acting Injectable to Prevent HIV