Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India

AIDS Research and Therapy
Joshi SmitaHIV Prevention Trial Network (HPTN) 047 Protocol Team

Abstract

The objective of this study was to evaluate the safety of twice daily, intra-vaginal use of 0.5% PRO 2000 Gel for fourteen days in HIV un-infected women at lower as well as higher risk for HIV acquisition, in Pune, India. Forty-two eligible volunteers (30 low-risk and 12 high-risk) were given 0.5% PRO 2000 Gel for intra-vaginal application twice daily for 14 consecutive days. Twenty-four participants (57%, 95% CI 41%-72%) experienced at least one adverse event (AE) judged to be possibly related to the product use. There were 17 (40%, 95% CI 26%-57%) mild AEs and 7 (17%, 95% CI 7%-31%) moderate AEs. There were no serious adverse events and no AEs judged probably or definitely related to product use. Genitourinary discomfort was reported by 2/30 (6.67%) participants in the low-risk cohort as compared to 4/12 (33.3%) women in the high-risk cohort (p = 0.03). Intermenstrual bleeding was reported in 2/30 (6.7%, 95% CI 1.0-22.1) women from the low risk cohort and 3/12 (25%, 95% CI 5.5-57.2) women from the high-risk cohort. One participant showed mild elevation of blood gamma glutamyl transferase and two showed mild elevations in total bilirubin. None of the participants showed detectable PRO 2000 in their blood after 14 days of produ...Continue Reading

References

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Jan 31, 2003·AIDS·Kenneth H MayerUNKNOWN HIV Prevention Trials Network (HPTN) 020 Protocol Team
May 25, 2004·Antimicrobial Agents and Chemotherapy·Natalia CheshenkoBetsy C Herold

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Citations

Feb 19, 2011·AIDS·Salim S Abdool KarimUNKNOWN HIV Prevention Trials Network (HPTN) 035 Study Team
Apr 18, 2009·Current Opinion in HIV and AIDS·Joseph RomanoPaulina E Kaptur
Mar 13, 2013·Protein & Cell·Yuanxi KangZhiwei Chen
Aug 23, 2008·Medicinal Research Reviews·Keduo QianKuo-Hsiung Lee
Mar 29, 2011·Antiviral Research·Vanessa PirroneFred C Krebs

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Methods Mentioned

BETA
contraception

Software Mentioned

SAS
StatXact

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