Human Immunodeficiency Virus (HIV) Clinical Trial
Official title:
HPTN 076 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre-Exposure Prophylaxis (PrEP)
This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.
This is a multi-site, double-blinded, two-arm, two:one randomized, placebo-controlled trial
comparing the safety of TMC278 LA for 48 weeks after the initial 1M injection to a saline
(0.9%NaCI) placebo IM injection among sexually active, HIV-uninfected women who are assessed
by the clinic staff as being at "low risk" for HIV acquisition (in keeping with a safety
trial). Approximately 132 women will be randomized to TMC278 LA and placebo in approximately
a two:one ratio (88 and 44 in the TMC278 LA and placebo arm, respectively).
Approximately 96 women will be enrolled in SSA and approximately 36 women will be enrolled in
the US. In order to screen for initial safety and tolerability of the active product, a
run-in period with oral rilpivirine will precede the injection of TMC278 LA. Participants
randomized to the placebo arm will receive oral placebo capsules prior to injection of saline
solution (0.9%NaCI). Participants will be observed while taking the study product by site
staff on approximately six occasions during the first two weeks of the oral run-in at Week 0
(Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between
Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single
follow-up visit. A subset of approximately 24 women at US sites will have vaginal tissue
collection for PK studies at a single follow-up visit (Tissue Subset).
Participants who present with Grade 2 or greater RELATED AEs during the oral-run in phase
will not receive the injectable TMC278 LA. Participants who present with Grade 3 or 4
UNRELATED AEs will not proceed to the injectable phase unless approved by the Clinical
Management Committee (CMC).
Arm 1: Participants randomized to the active arm will receive rilpivirine 25 mg capsules once
daily for four weeks to be taken orally with a meal. Participants will then receive IM
injections of TMC278 LA, 1200 mg dose, at eight week intervals (at Weeks 4, 12, 20, 28, 36
and 44). On each dosing occasion 1200 mg of TMC278 LA will be delivered in two, 2 mL
injections, one in each gluteus maximus muscle. All participants will receive a total of six
doses (12 IM injections).
Arm 2: Participants randomized to the placebo arm will receive placebo capsules once daily
for four weeks to be taken orally with a meal. Participants will then receive IM injections
of saline (0.9% NaCI) at eight week intervals (at Weeks 4, 12, 20, 28, 36 and 44). On each
dosing occasion placebo will be delivered in two, 2 mL injections, one in each gluteus
maximus muscle. All participants will receive a total of six doses (12 IM injections).
Study sites:
- Bronx Prevention Center CRS, USA
- New Jersey Medical School CRS, USA
- Emavundleni CRS, Cape Town, South Africa
- Spilhaus CRS, Harare, Zimbabwe
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