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Study
Status Table
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& Sites Table
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Phase Definitions
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HPTN 032
Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)
What is HPTN
032?
HPTN 032 is an HIV prevention trial involving
HIV-positive men in the Seattle, WA area. The study's purpose
is to assess the toxicity and acceptability of a topical microbicide when
applied to the penis of HIV-infected men. This kind of assessment is
important in determining the future viability of similar products in
preventing the transmission of HIV.
The study has completed enrollment,
follow-up, and data analysis. Results demonstrated that the daily
application of the study's topical microbicide products directly to the
penis consecutively for 7 days was generally safe and well tolerated among
men participating in the study.
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HPTN 032 paper published!
The HPTN study paper was published
in the August 1, 2003 issue of the Journal of Acquired Immune Deficiency
Syndromes. The article is also available in PDF format to those with a
subscription to JAIDS by following the link within the citation below.
The paper itself contains data analysis from
two other studies in addition to HPTN 032. Those studies were conducted in
Los Angeles, CA and Houston, TX, and targeted both HIV-positive and HIV-negative
men. The combined data provide a more complete picture of the prospective
use of topical microbicides.
Please feel free to click on the link below and
download the documents in PDF format. The article is copyrighted 2003 by the
publisher, Lippincott Williams & Wilkins.
Tabet SR, Callahan MM, Mauck CK, Gai F, Coletti
AS, Profy AT, Moench TR, Soto-Torres LE, Poindexter AN, Frezieres RG, Walsh TL,
Kelly CW, Richardson BA, van Damme L, Celum CL. Safety
and Acceptability of Penile Application of 2 Candidate Topical Microbicides:
BufferGel and PRO 2000 Gel: 3 Randomized Trials in Healthy Low-Risk Men and
HIV-Positive Men. J Acquir Immune Defic Syndr. 2003, 33: 476-83.
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Protocol Status:
Concluded
Study Summary
Study Purpose: To assess the toxicity and acceptability of BufferGel and PRO 2000/5 Gel (P) when applied to the penis of HIV-infected men, compared to a placebo control gel.
Study Design: Phase I, randomized, blinded, crossover study with one week of exposure to each of BufferGel, PRO 2000 Gel (P), and a placebo control gel. Each week of exposure is separated by a one-week washout period.
Study Population: Circumcised and uncircumcised HIV-infected men residing in the Seattle, WA area.
Study Size: 24 participants total (12 circumcised, 12 uncircumcised)
Study Duration: Approximately eight months total. Accrual required six-and-a-half months and each participant is followed for a minimum of five weeks.
Treatment Regimen: Nightly application of 2 mL of BufferGel, PRO 2000/5 Gel (P), or placebo gel for a period of seven consecutive nights each. Gel is applied to the shaft and glans of the penis at bedtime, left on for a minimum of six hours, and washed off the next morning.
Primary Objectives: To assess the toxicity of BufferGel and PRO 2000/5 Gel (P) on the penile epithelium and urethral mucosa of HIV-infected men.
Secondary Objectives: To assess the acceptability of BufferGel and PRO 2000/5 Gel (P) among HIV-infected men.
Protocol Chair:
Connie Celum
get info
CORE Protocol Specialist:
Anne Coletti
get info
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