McLean, Catherine, Heidi Jones, Janet McNicholl, Janneke van de Wijgert, Tepnaruemit Medtanavyn, Wat Uthaiworavit, Sara Whitehead, John Karon, and Lauri Markowitz. "Effect of Carraguard™ gel use on cell-free HIV-1 RNA cervicovaginal shedding in HIV-infected women: A Phase 1 randomized, controlled crossover study in Chiang Rai, Thailand."

Abstract

BACKGROUND: Vaginal microbicides to prevent HIV transmission may be used by HIV-infected women. As part of a safety evaluation, the impact on cervicovaginal HIV viral shedding must be evaluated. We conducted a Phase 1, three-treatment (Carraguard gel, methylcellulose placebo gel, and no product) crossover study among 60 HIV-infected women in northern Thailand.

METHODOLOGY: Eligibility criteria included a CD4 cell count of 50–500 cells/µL, not currently taking antiretroviral therapy, and regular menstrual cycles. Randomized to one of six treatment sequences, participants were enrolled for 3 months (one treatment per month). Each treatment month started shortly after the end of menses, and women were instructed to insert gel vaginally (or to use no product) once daily for 7 days. Cervicovaginal lavage (CVL) specimens were collected on day 0 (baseline), at 15 minutes after the first gel application, and at days 7 and 14 of each month. HIV-1 viral loads were determined using the Roche Amplicor Monitor HIV-1 kit (1.5).

RESULTS: Age, sexual behaviors, baseline CD4 cell counts, plasma HIV viral loads (PVL), or CVL HIV viral loads (median, 2.1 log₁₀ copies/ml) were similar at enrollment among the randomization groups; PVL and CVL viral loads were correlated (Spearman correlation, r=0.7). Fifteen minutes after treatment 1, half the women had quantifiable CVL viral loads (>1.9 log₁₀ copies/ml) but more than half had undetectable viral loads after treatments 2 and 3 (p<0.001). At day 7, median CVL viral loads were quantifiable (2.03 log₁₀ copies/ml) during treatment 1 and detectable but below the assay limit for quantification (<1.9 log₁₀ copies/ml) during treatments 2 and 3 (p<0.001). At day 14 (7 days after gel use ended), CVL viral loads were similar during the 3 treatments (p = 0.33, overall median 2.0 log₁₀ copies/ml).

CONCLUSIONS: Using a crossover study design, we found no increase in cervicovaginal, cell-free HIV-1 shedding in any of the three (blinded) treatments; gel use (with or without Carraguard) did not increase HIV-1 shedding. Following 15 minutes and 7 days of gel use, there was a significant decrease in cervicovaginal cell-free HIV in two arms, which resolved at day 14.

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Microbicides 2006

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This page updated 3 April 2006

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