Phase 1 trial of the topical microbicide BufferGel

Safety results from four international sites

Janneke Van De Wijgert, Andrew Fullem, Clifton Kelly, Sanjay Mehendale, Sungwal Rugpao, Newton Kumwenda, Zvavahera Chirenje, Smita Joshi, Taha E Taha, Nancy Padian, Robert C Bollinger, Kenrad Edwin Nelson

Research output: Contribution to journalArticle

Abstract

Aim: To evaluate the safety of BufferGel (ReProtect LLC, Baltimore, MD), a spermicidal microbicide that acidifies semen and maintains the protective acidity of the vagina, in a high-dose tolerance trial. Methods: HIV/STD negative, sexually abstinent, and sexually active women in India, Thailand, Malawi, and Zimbabwe were asked to insert one applicator (∼5 ml) of BufferGel vaginally twice per day for 14 days. Sexually active women agreed to have sex (while using BufferGel and nonlubricated condoms) at least twice per week. Results: In total, 98 women (30 sexually abstinent and 68 sexually active) were enrolled. Overall compliance with product use was 93%. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (8 cases in 271 examinations). Irritation was reported by approximately one quarter of the women (0.58 events per woman-week) but was generally mild and of short duration. The prevalence of bacterial vaginosis (BV) fell significantly, from 30% at enrollment to 6% at one week, and 7% at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only 3 developed symptomatic vaginitis. Conclusion: BufferGel appears to be safe and well tolerated by the cervicovaginal epithelium. Its effect on BV and yeasts merits further study.

Original languageEnglish (US)
Pages (from-to)21-27
Number of pages7
JournalJournal of Acquired Immune Deficiency Syndromes
Volume26
Issue number1
StatePublished - Jan 1 2001

Fingerprint

Local Anti-Infective Agents
Safety
Bacterial Vaginosis
Yeasts
Vaginitis
Malawi
Zimbabwe
Gynecological Examination
Baltimore
Colposcopy
Condoms
Vagina
Thailand
Sexually Transmitted Diseases
Anti-Infective Agents
Semen
BufferGel
India
Epithelium
HIV

Keywords

  • Anti-infective agents
  • HIV prevention
  • Phase I clinical trial
  • Vaginal spermicide

ASJC Scopus subject areas

  • Virology
  • Immunology

Cite this

Van De Wijgert, J., Fullem, A., Kelly, C., Mehendale, S., Rugpao, S., Kumwenda, N., ... Nelson, K. E. (2001). Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites. Journal of Acquired Immune Deficiency Syndromes, 26(1), 21-27.

Phase 1 trial of the topical microbicide BufferGel : Safety results from four international sites. / Van De Wijgert, Janneke; Fullem, Andrew; Kelly, Clifton; Mehendale, Sanjay; Rugpao, Sungwal; Kumwenda, Newton; Chirenje, Zvavahera; Joshi, Smita; Taha, Taha E; Padian, Nancy; Bollinger, Robert C; Nelson, Kenrad Edwin.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 26, No. 1, 01.01.2001, p. 21-27.

Research output: Contribution to journalArticle

Van De Wijgert, J, Fullem, A, Kelly, C, Mehendale, S, Rugpao, S, Kumwenda, N, Chirenje, Z, Joshi, S, Taha, TE, Padian, N, Bollinger, RC & Nelson, KE 2001, 'Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites', Journal of Acquired Immune Deficiency Syndromes, vol. 26, no. 1, pp. 21-27.
Van De Wijgert J, Fullem A, Kelly C, Mehendale S, Rugpao S, Kumwenda N et al. Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites. Journal of Acquired Immune Deficiency Syndromes. 2001 Jan 1;26(1):21-27.
Van De Wijgert, Janneke ; Fullem, Andrew ; Kelly, Clifton ; Mehendale, Sanjay ; Rugpao, Sungwal ; Kumwenda, Newton ; Chirenje, Zvavahera ; Joshi, Smita ; Taha, Taha E ; Padian, Nancy ; Bollinger, Robert C ; Nelson, Kenrad Edwin. / Phase 1 trial of the topical microbicide BufferGel : Safety results from four international sites. In: Journal of Acquired Immune Deficiency Syndromes. 2001 ; Vol. 26, No. 1. pp. 21-27.
@article{234dfd15221c4558ade803ddcc7ae17c,
title = "Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites",
abstract = "Aim: To evaluate the safety of BufferGel (ReProtect LLC, Baltimore, MD), a spermicidal microbicide that acidifies semen and maintains the protective acidity of the vagina, in a high-dose tolerance trial. Methods: HIV/STD negative, sexually abstinent, and sexually active women in India, Thailand, Malawi, and Zimbabwe were asked to insert one applicator (∼5 ml) of BufferGel vaginally twice per day for 14 days. Sexually active women agreed to have sex (while using BufferGel and nonlubricated condoms) at least twice per week. Results: In total, 98 women (30 sexually abstinent and 68 sexually active) were enrolled. Overall compliance with product use was 93{\%}. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (8 cases in 271 examinations). Irritation was reported by approximately one quarter of the women (0.58 events per woman-week) but was generally mild and of short duration. The prevalence of bacterial vaginosis (BV) fell significantly, from 30{\%} at enrollment to 6{\%} at one week, and 7{\%} at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only 3 developed symptomatic vaginitis. Conclusion: BufferGel appears to be safe and well tolerated by the cervicovaginal epithelium. Its effect on BV and yeasts merits further study.",
keywords = "Anti-infective agents, HIV prevention, Phase I clinical trial, Vaginal spermicide",
author = "{Van De Wijgert}, Janneke and Andrew Fullem and Clifton Kelly and Sanjay Mehendale and Sungwal Rugpao and Newton Kumwenda and Zvavahera Chirenje and Smita Joshi and Taha, {Taha E} and Nancy Padian and Bollinger, {Robert C} and Nelson, {Kenrad Edwin}",
year = "2001",
month = "1",
day = "1",
language = "English (US)",
volume = "26",
pages = "21--27",
journal = "Journal of Acquired Immune Deficiency Syndromes",
issn = "1525-4135",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - Phase 1 trial of the topical microbicide BufferGel

T2 - Safety results from four international sites

AU - Van De Wijgert, Janneke

AU - Fullem, Andrew

AU - Kelly, Clifton

AU - Mehendale, Sanjay

AU - Rugpao, Sungwal

AU - Kumwenda, Newton

AU - Chirenje, Zvavahera

AU - Joshi, Smita

AU - Taha, Taha E

AU - Padian, Nancy

AU - Bollinger, Robert C

AU - Nelson, Kenrad Edwin

PY - 2001/1/1

Y1 - 2001/1/1

N2 - Aim: To evaluate the safety of BufferGel (ReProtect LLC, Baltimore, MD), a spermicidal microbicide that acidifies semen and maintains the protective acidity of the vagina, in a high-dose tolerance trial. Methods: HIV/STD negative, sexually abstinent, and sexually active women in India, Thailand, Malawi, and Zimbabwe were asked to insert one applicator (∼5 ml) of BufferGel vaginally twice per day for 14 days. Sexually active women agreed to have sex (while using BufferGel and nonlubricated condoms) at least twice per week. Results: In total, 98 women (30 sexually abstinent and 68 sexually active) were enrolled. Overall compliance with product use was 93%. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (8 cases in 271 examinations). Irritation was reported by approximately one quarter of the women (0.58 events per woman-week) but was generally mild and of short duration. The prevalence of bacterial vaginosis (BV) fell significantly, from 30% at enrollment to 6% at one week, and 7% at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only 3 developed symptomatic vaginitis. Conclusion: BufferGel appears to be safe and well tolerated by the cervicovaginal epithelium. Its effect on BV and yeasts merits further study.

AB - Aim: To evaluate the safety of BufferGel (ReProtect LLC, Baltimore, MD), a spermicidal microbicide that acidifies semen and maintains the protective acidity of the vagina, in a high-dose tolerance trial. Methods: HIV/STD negative, sexually abstinent, and sexually active women in India, Thailand, Malawi, and Zimbabwe were asked to insert one applicator (∼5 ml) of BufferGel vaginally twice per day for 14 days. Sexually active women agreed to have sex (while using BufferGel and nonlubricated condoms) at least twice per week. Results: In total, 98 women (30 sexually abstinent and 68 sexually active) were enrolled. Overall compliance with product use was 93%. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (8 cases in 271 examinations). Irritation was reported by approximately one quarter of the women (0.58 events per woman-week) but was generally mild and of short duration. The prevalence of bacterial vaginosis (BV) fell significantly, from 30% at enrollment to 6% at one week, and 7% at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only 3 developed symptomatic vaginitis. Conclusion: BufferGel appears to be safe and well tolerated by the cervicovaginal epithelium. Its effect on BV and yeasts merits further study.

KW - Anti-infective agents

KW - HIV prevention

KW - Phase I clinical trial

KW - Vaginal spermicide

UR - http://www.scopus.com/inward/record.url?scp=0035144537&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035144537&partnerID=8YFLogxK

M3 - Article

VL - 26

SP - 21

EP - 27

JO - Journal of Acquired Immune Deficiency Syndromes

JF - Journal of Acquired Immune Deficiency Syndromes

SN - 1525-4135

IS - 1

ER -