Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213005
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2005-09-13
Brief Title:
Safety and Acceptability of Carraguard in HIV Positive Women and Men
Sponsor:
Population Council
Organization:
Population Council
Study Overview
Official Title:
A Phase 1 Safety and Acceptability Study of Carraguard Among HIV Positive Women and Men in Durban South Africa
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study objectives were to assess the mucosal safety of Carraguard gel when applied vaginally once per day for 14 days by sexually abstinent and sexually active HIV-positive women to evaluate the effect of Carraguard gel on the vaginal flora in these women to evaluate the effect of Carraguard gel on shedding of HIV-1 in the genital tract of these women to evaluate the safety of Carraguard gel when applied directly to the penis once per day for 7 days by sexually abstinent HIV-positive men to assess whether symptoms reported by female and male participants during the study may be related to the use of Carraguard gel and to examine dimensions of the acceptability of and compliance with the study and placebo products
Detailed Description:
We proposed a safety study of the Councils lead candidate microbicide Carraguard in three cohorts in Durban South Africa sexually abstinent HIV-positive women sexually abstinent HIV-positive men and sexually active HIV-positive women Sexually active women must be in an HIV-positive seroconcordant relationship confirmed by HIV testing of the woman and her male partner and written informed consent was obtained from the male partners Women and men in each cohort were randomized to one of three study groups Carraguard gel its matching placebo methyl-cellulose gel or no product
The main objectives of this study were to investigate changes in the vulvar vaginal and cervical epithelia the vaginal flora and HIV-1 shedding in the genital tract of female participants and changes of the penile skin and epithelia of male participants We also evaluated symptoms reported by participants and several dimensions of the acceptability of and compliance with the study or placebo gel Reactions to a non-contraceptive microbicide were assessed as well as reasons for voluntary discontinuation and non-use of Carraguard or the placebo determined by review of daily diary was recorded Exit focus group discussions were held with male and female participants to discuss aspects of acceptability and compliance Self-reported symptoms were also investigated by clinical examination as needed and study endpoints included genital itching or burning frequent urination burning while urinating genital pain pain during sex and abnormal vaginal or penile discharge
The main objectives of this study were to investigate changes in the vulvar vaginal and cervical epithelia the vaginal flora and HIV-1 shedding in the genital tract of female participants and changes of the penile skin and epithelia of male participants We also evaluated symptoms reported by participants and several dimensions of the acceptability of and compliance with the study or placebo gel Reactions to a non-contraceptive microbicide were assessed as well as reasons for voluntary discontinuation and non-use of Carraguard or the placebo determined by review of daily diary was recorded Exit focus group discussions were held with male and female participants to discuss aspects of acceptability and compliance Self-reported symptoms were also investigated by clinical examination as needed and study endpoints included genital itching or burning frequent urination burning while urinating genital pain pain during sex and abnormal vaginal or penile discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None