Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT00213057
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand
Sponsor:
Population Council
Organization:
Study Overview
Official Title:
A Randomized, Placebo-controlled, Double-blind Trial to Assess Expanded Safety and Acceptability of Carraguard™ (PC-515) Vaginal Gel Among Heterosexual Couples in Chiang Rai
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 primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.
Detailed Description:
Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a triple-masked, randomized, placebo-controlled trial fielded in one site in Chiang Rai, northern Thailand. The primary aims of the study were to assess Carraguard's safety (toxicity) in both men and women - including signs of local irritation, such as itching or burning; changes in vaginal flora (women); and incidence of abnormal external genital, vaginal (women), and cervical findings (women) - when applied vaginally prior to intercourse for 6 months; to evaluate acceptability; to gauge men's and women's reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a Thai population.
Secondary aims were to investigate sexually transmitted infections averted - including HIV, C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications) in men and women; bacterial vaginosis and candidaisis in women; and balanitis in men; and effect on cervical cytology.
Secondary aims were to investigate sexually transmitted infections averted - including HIV, C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications) in men and women; bacterial vaginosis and candidaisis in women; and balanitis in men; and effect on cervical cytology.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDC Protocol #2968 | None | None | View |