First Phase 1 Trial of UC781 Gel as a Rectal Microbicide
Author Information
Author(s): Anton Peter A., Saunders Terry, Elliott Julie, Khanukhova Elena, Dennis Robert, Adler Amy, Cortina Galen, Tanner Karen, Boscardin John, Cumberland William G., Zhou Ying, Ventuneac Ana, Carballo-Diéguez Alex, Rabe Lorna, McCormick Timothy, Gabelnick Henry, Mauck Christine, McGowan Ian
Primary Institution: Center for HIV Prevention Research, UCLA AIDS Institute, Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles
Hypothesis
Can UC781 gel be safely used as a rectal microbicide to reduce HIV transmission?
Conclusion
The UC781 gel was safe for rectal use, showed high acceptability, and demonstrated marked suppression of HIV infectibility in ex vivo biopsy infections.
Supporting Evidence
- 100% retention of participants throughout the study.
- No Grade 3 or 4 adverse events reported.
- Marked suppression of HIV infectibility in ex vivo biopsy infections with 0.25% UC781.
- High acceptability reported by participants for future use of the gel.
- Plasma levels of UC781 were not detected in participants.
Takeaway
This study tested a gel to help prevent HIV when used in the rectum, and it was found to be safe and liked by participants.
Methodology
A double-blind, placebo-controlled trial with 36 HIV-1 seronegative participants using two concentrations of UC781 gel.
Potential Biases
Potential bias in self-reported acceptability measures.
Limitations
The study was limited by the small sample size and the lack of detectable plasma levels of UC781.
Participant Demographics
36 participants, median age 41, 72% male, 41% African American, 39% Caucasian.
Statistical Information
P-Value
p<0.05
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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