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02586 HIGH RATES OF CO-MORBID CONDITIONS & PELVIC FINDINGS IN HIV+ WOMEN ENROLLED IN HPTN049 El-Sadr, Wafaa Background: The availability of effective vaginal microbicides is a key HIV prevention strategy. The assessment of the safety of these products HIV-infected persons is important as they are likely to be used by these populations. Objectives: To describe the characteristics of HIV-infected women enrolled in an ongoing phase I double blind placebo controlled microbicide study of cellulose sulphate Methods: HIV-infected women were enrolled at 4 US sites after screening for exclusion criteria. Baseline demographic and HIV disease characteristics, prior medical history, a pelvic examination and colposcopy were conducted. Results: A total of 55 women were enrolled with mean age of 37.9 years, 64% African American, 15% Latino and 20% white. At baseline, mean CD4+ lymphocyte count was 588+245 cells/mm3 and viral load 4,275 copies/mm3. Antiretroviral drugs were used by 71% at baseline. History of depression was reported by 40%, anemia 24%, hepatitis C 24%, asthma 16%, hypertension 15% and diabetes 5%. History of bacterial vaginosis was reported by 9%, trichomonas by 5%, and chlamydia, gonorrhea, syphilis by 1 woman each. At enrollment, 7% and 49% had abnormal pelvic and colposcopic exams, respectively. The following colposcopic findings were noted: erythema (22%), petechiae/echymosis (20%), abrasion (5%), ulceration (4%), cysts (15%) and peeling (2%). Conclusions: A high rate of co-morbid conditions, prior pelvic infections and colposcopic findings were noted in this highly selected group of HIV+ women. These findings highlight the complexities of enrolling such women and the need for pragmatic eligibility criteria. The data also support the need for determination of the safety of microbicide candidates in this population. Wafaa El-Sadr, MD, MPH |
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