29810
document
Safety trial of the vaginal microbicide cellulose sulfate gel in HIV-positive men . OBJECTIVE Cellulose sulfate ( CS ) is a promising vaginal microbicide . Because men will be exposed to the microbicide when engaging in vaginal intercourse , safety and acceptability need to be assessed in men . DESIGN This randomized double-blind phase I study assessed the safety and acceptability of seven consecutive daily doses of CS versus KY Jelly in 36 HIV-positive men . RESULTS No new or worsening of existing genital findings were observed during the follow-up examination . Mild genital symptoms were reported in 42 % of CS users ( itching , burning , tingling , testicular pain , dysuria , and warm or cold feeling ) and 8 % of KY Jelly users . CONCLUSION CS gel applied to the penis was well tolerated in this HIV-positive male population . The itching and burning symptoms were not severe and can be explained by the preservative benzyl alcohol present in the CS gel .
29811
Intervention_Pharmacological
vaginal microbicide cellulose sulfate gel
29812
Intervention_Pharmacological
Cellulose sulfate ( CS )
29813
Intervention_Pharmacological
CS
29814
Intervention_Pharmacological
KY Jelly
29815
Intervention_Pharmacological
CS
29816
Intervention_Pharmacological
KY
29817
Intervention_Pharmacological
CS
29818
Intervention_Pharmacological
CS
29819
Outcome_Other
safety and acceptability
29820
Outcome_Other
safety and acceptability
29821
Outcome_Physical
new or worsening of existing genital findings
29822
Outcome_Physical
Mild genital symptoms
29823
Outcome_Physical
itching
29824
Outcome_Physical
burning
29825
Outcome_Physical
tingling
29826
Outcome_Physical
testicular pain
29827
Outcome_Physical
dysuria
29828
Outcome_Physical
warm or cold feeling
29829
Outcome_Other
tolerated
29830
Outcome_Physical
itching and burning
29831
Participant_Condition
HIV-positive
29832
Participant_Sex
men
29833
Participant_Sex
men
29834
Participant_Sex
men
29835
Participant_Sample-size
36
29836
Participant_Condition
HIV-positive
29837
Participant_Sex
men
29838
Participant_Condition
HIV-positive
29839
Participant_Sex
male