Safety and Acceptability of Carraguard® in HIV Positive Women and Men
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
|Official Title:||A Phase 1 Safety and Acceptability Study of Carraguard® Among HIV Positive Women and Men in Durban, South Africa|
- Safety: genital findings, epithelial disruption, vaginal flora changes, genital shedding, inflammation & self-reported symptoms. Assessments were made weekly at days 7, 14 & 21.
- Acceptability: interviewer-administered questionnaires & daily diaries. Interviewer-administered questionnaires assessed at day 21 & daily diaries were assessed at days 14 and 21.
|Study Start Date:||June 2002|
|Estimated Study Completion Date:||August 2003|
We proposed a safety study of the Council’s 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.
|Medical Research Council|
|Durban, South Africa|
|Principal Investigator:||Janneke van de Wijgert, Ph.D.||International Antiviral Therapy Evaluation Center|
|Principal Investigator:||Gita Ramjee, Ph.D||Medical Research Council|