Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213031
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2005-09-13
Brief Title:
Safety Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide
Sponsor:
Population Council
Organization:
Population Council
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Trial to Assess Expanded Safety Acceptability and Preliminary Effectiveness of PC-515 Lambda Carrageenan for Vaginal Use as a Possible Microbicide
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 PC-515 when applied vaginally at least three times weekly for 12 months Secondary aims were to gather preliminary data on Carraguards effectiveness in preventing male-to-female transmission of HIV and other STIs
The hypothesis was that Carraguard would cause little or no significant irritation including lesions and 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 trial
The hypothesis was that Carraguard would cause little or no significant irritation including lesions and 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 trial
Detailed Description:
Carraguard PC-515 the Population Councils 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 Carraguards safety toxicity - including signs of local irritation such as itching or burning changes in vaginal flora and incidence of abnormal external genital vaginal and cervical findings - when applied vaginally for 12 months to evaluate acceptability to assess feasibility of conducting a large scale microbicide trial in a non-sex worker population to gauge womens reactions to a non-contraceptive microbicide and to explore microbicide use dynamics in a Thai population
Secondary aims were to investigate HIV infections averted preliminary indications other sexually transmitted infections averted - including C trachomatis N gonorrhoeae T vaginalis and T pallidum preliminary indications and effect on cervical cytology
Secondary aims were to investigate HIV infections averted preliminary indications other sexually transmitted infections averted - including C trachomatis N gonorrhoeae T vaginalis and T pallidum preliminary indications and effect on cervical cytology
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 |
|---|---|---|---|
| CDC Prevention 2485 | None | None | None |