Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213018
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2005-09-13
Brief Title:
Safety Acceptability and Preliminary Effectiveness of Carraguard PC-515 in Preventing HIVSTI Transmission
Sponsor:
Population Council
Organization:
Population Council
Study Overview
Official Title:
A Trial to Assess Expanded Safety Acceptability and Preliminary Effectiveness of Carraguard PC-515 in Preventing STIHIV Transmission
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 PC-515 when applied vaginally at least three times weekly for 6-12 months Secondary aims were to gather preliminary data on Carraguards effectiveness in preventing male-to-female transmission of HIV
The hypothesis was that Carraguard would cause little or no significant irritation including lesions that women would find Carraguard acceptable The study was not powered to determine effectiveness but based on safety acceptability and feasibility parameters the outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 efficacy trial
The hypothesis was that Carraguard would cause little or no significant irritation including lesions that women would find Carraguard acceptable The study was not powered to determine effectiveness but based on safety acceptability and feasibility parameters the outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 efficacy trial
Detailed Description:
Carraguard PC-515 the Population Councils lead candidate microbicide was tested in a triple-masked randomized placebo-controlled trial fielded in two sites in South Africa The primary aims of the study were to assess Carraguards safety toxicity - including signs of irritation such as itching or burning changes in vaginal flora and incidence of abnormal external genital vaginal and cervical findings - when applied vaginally for durations of 6-12 months and to evaluate several dimensions of the acceptability of Carraguard and placebo products Secondary aims were to investigate whether study participants using Carraguard had lower rates of HIV seroconversion or other sexually transmitted infections including C trachomatis N gonorrhoeae T vaginalis and T pallidum than the placebo methyl cellulose gel In addition when it began this trial was the first to explore the feasibility of large-scale microbicides testing in a non-sex worker population Last the trial gauged womens reactions to using a non-contraceptive product in vitro testing had shown that Carraguard has no contraceptive effect as well as potential use-dynamics in communities where drying agents and other traditional vaginal products are used with high frequency
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AI045468-02 | NIH | None | httpsreporternihgovquickSearchR01AI045468-02 |