Jones, Heidi, Sarah Braunstein, Tammy Evans-Strickfaden, Neetha S. Morar, Gita Ramjee, Clyde Hart, and Janneke van de Wijgert. "Effect of Carraguard™ gel on cell-free HIV-1 RNA shedding in genital secretions of HIV-positive women: A Phase 1 safety study in Durban, South Africa."

Abstract

BACKGROUND: Many women at risk for HIV who may want to use a vaginal microbicide do not know their HIV status. We therefore assessed safety of Carraguard™ gel in HIV-positive women in Durban, South Africa, including effects on genital HIV shedding.

METHODS: The study was a randomized, placebo and no-gel controlled, Phase 1, triple-blinded, safety trial among 40 HIV-positive sexually abstinent and active women with CD4+ count >200. Women randomized to the gel groups were asked to use gel once a day for 14 days, and before sex (sexually active group only). Phosphate-buffered saline lavages of the cervico-vaginal mucosa (CVLs) were collected at days 0 (before gel use), 7, 14, and 21 (7 days after gel cessation). Blood plasma viral loads and CD4+ cell counts were measured at screening and day 14. Blood and CVL viral loads were determined using the Roche Amplicor Monitor HIV-1 assay (version 1.5).

RESULTS: Twenty women each, with a median age of 28 years (range 19–43), were enrolled in the sexually abstinent and active groups, and 39 completed the study. At the screening visit, median plasma viral load and CD4+ cell count were 4.5 log₁₀ copies/ml and 409 cells/µL, respectively. At baseline, median CVL virus loads were similar among women in the three study arms, and plasma and CVL viral loads were well correlated (Spearmans correlation, r=0.65). After 7 and 14 days of gel use, median CVL virus loads remained similar among the three arms, and plasma and CVL remained correlated (r=0.68). Few women had a clinically significant increase in CVL viral load (defined as an increase of 0.5 log₁₀ copies/ml or greater, or a shift from nondetectable to nonquantifiable, or nonquantifiable to quantifiable), and they were evenly distributed across study arms, with CVL viral loads for two women in each arm significantly increasing between days 0 and 7. Similarly, only 1–2 women in each arm showed a clinically significant increase in CVL viral load between days 0 and 14.

CONCLUSION: Exposure to Carraguard gel for 14 days did not increase HIV-1 RNA genital shedding in this study.

Track B: Empirical Findings of Phase 1 and 2 Trials of New Microbicide Products (Including Rectal Microbicides)
Monday, 24 April 2006, 10:45 am–12:30 pm

Microbicides 2006

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This page updated 3 April 2006

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