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document
Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women . OBJECTIVES Few studies of topical microbicides have assessed their safety in HIV-infected women . We conducted this study to evaluate the safety and acceptability of 6 % cellulose sulfate ( CS ) gel as a vaginal microbicide in sexually abstinent and active HIV-infected women . METHODS Fifty-nine HIV-infected women were enrolled in a randomized double-blind placebo-controlled study comparing 6 % CS to placebo gel used for 14 days . Sexually abstinent women applied gel once or twice daily and sexually active women used gel once daily . RESULTS CS gel was safe with no reported severe or life-threatening adverse events ( AE ) . Thirty-nine ( 66 % ) of the participants experienced urogenital AE judged as probably or possibly related to gel . The majority ( 51 % ) of these participants reported only mild events . Fewer women ( 62 % ) who used CS experienced urogenital AE than those assigned to placebo gel ( 70 % ) ( P = 0.59 ) . Eleven ( 19 % ) women experienced intermenstrual bleeding judged to be probably or possibly related to gel use ( four in the CS and seven in the placebo gel group ) . There was no increase in AE by frequency of gel use or sexual activity with the exception of abdominal/pelvic pain which was noted more frequently with twice daily use among sexually abstinent women . Women and men found the gel highly acceptable . CONCLUSIONS This Phase I study demonstrated that CS vaginal gel was safe , well tolerated and acceptable by HIV-infected women and their male partners . Thus , further development of CS is warranted as a potential method to prevent HIV transmission and acquisition .
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Intervention_Pharmacological
cellulose sulfate
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Intervention_Pharmacological
cellulose sulfate ( CS )
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
CS
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Intervention_Control
placebo gel
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Intervention_Control
placebo
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Intervention_Pharmacological
CS vaginal gel
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Outcome_Other
safety in HIV-infected women
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Outcome_Other
safety and acceptability
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Outcome_Adverse-effects
severe or life-threatening adverse events ( AE )
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Outcome_Adverse-effects
urogenital AE
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Outcome_Adverse-effects
mild events
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Outcome_Adverse-effects
urogenital AE
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Outcome_Adverse-effects
intermenstrual bleeding
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Outcome_Adverse-effects
AE
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Outcome_Adverse-effects
abdominal/pelvic pain
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Outcome_Other
safe , well tolerated and acceptable
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Outcome_Physical
HIV transmission and acquisition