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02577_1 EVALUATION OF HIV-INFECTED WOMEN SCREENED FOR A CLINICAL TRIAL OF MICROBICIDE SAFETY, THAILAND McLean, Catherine* Background: Few candidate microbicide safety trials have been conducted among HIV-infected women. We screened HIV-infected women for participation in a safety and acceptability trial of a candidate microbicide (Carraguard) in Northern Thailand. Eligibility criteria included abstinence or an HIV-infected husband/steady sex partner, regular menstrual cycles, not currently taking antiretroviral (ARV) therapy, and a CD4 cell count of 50-500 cells/µL. We report the clinical findings from women screened. Methods: HIV and syphilis serological tests and CD4 cell counts were performed for all women screened. Women were referred for HIV clinical evaluation, including chest radiograph, and received pneumocystis carinii (PCP) and/or fungal prophylaxis, if indicated. For women meeting preliminary eligibility criteria, a pelvic examination with Pap smear was performed. Husbands/steady sex partners were offered HIV testing. Results: Overall, 144 women were screened; nine (6%) tested HIV negative. Among 135 HIV-infected women, 40 (30%) did not meet CD4 cell count criteria; 26 (19%) had <50 CD4 cells/µL, and 14 (10%) had >500 CD4 cells/µL. Overall, 64 (47%) women had CD4 cell counts <200 cells/µL. Among 114 women with HIV care evaluations, 40 (35%) received fungal and/or PCP prophylaxis. Among 95 women with CD4 50-500 cells/µL, 53 (56%) were abstinent. Thirty-four (36%) had a husband/steady sex partner who was tested for HIV, and 19 (56%) tested HIV positive. Six (4%) had reactive serologic tests for syphilis and were treated. Pap smear results were available for 57 women tested; eight (14%) were > Class II, and these women were referred for colposcopy and excluded from participation. One woman was diagnosed with active tuberculosis, received treatment, and was excluded. At this time, 35 women have been enrolled. Conclusions: As part of screening for this study, women learned their CD4 count and received care for HIV-related conditions. For those eligible, knowledge of CD4 count may increase their ability to access to antiretroviral treatment. Overall, 47% of women screened may be eligible for ARVs as the Thai government expands HIV treatment programs for persons with CD4 cell counts <200 cells/µL; many may not have been previously aware of their eligibility. We identified many discordant couples who received intensive counselling to reduce the risk of HIV transmission to the uninfected partner. Dr. Catherine McLean |
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