Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441298
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2007-02-27
Brief Title:
Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV
Sponsor:
Centre for the AIDS Programme of Research in South Africa
Organization:
Centre for the AIDS Programme of Research in South Africa
Study Overview
Official Title:
Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1 Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IIb two-arm double-blinded randomised placebo controlled trial comparing 1 Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection Participants will be provided with a supply of single-use pre-filled applicators according to their randomisation While in the study participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus All participants will receive HIV risk reduction counselling condoms and syndromic treatment of sexually transmitted infections if required
Detailed Description:
Purpose To assess the safety and effectiveness of tenofovir gel a candidate vaginal microbicide in sexually active women at risk for human immunodeficiency virus HIV infection in South Africa
Design Phase IIb two-arm double-blind randomised controlled trial comparing 1 tenofovir gel with a placebo gel
Study Population Sexually active HIV-uninfected women aged 18 to 40 years in South Africa
Study Size 900 women
Treatment Regimen Participants will be provided with a supply of single-use pre-filled applicators according to their randomisation While in the study participants will be asked to apply a first dose of the assigned study product 1 tenofovir gel or placebo gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus They will be advised to use only two doses of gel in a 24-hour period
Study Duration Approximately 30 months in total Accrual will require approximately 14 months and follow-up will continue until 92 incident HIV infections are observed in the study which is expected to occur approximately 16 months after the end of the accrual period
Primary Objective
To evaluate the effectiveness and safety of a candidate vaginal microbicide tenofovir gel when applied intravaginally by women in preventing sexually transmitted HIV infection
Secondary Objectives
To assess the impact if any of tenofovir gel on the incidence rate of deep epithelial disruption
To assess the impact if any of tenofovir gel on viral load in women who become infected with HIV during the trial
To assess tenofovir resistance in HIV seroconvertors in the trial
To ascertain the impact if any of tenofovir gel on pregnancy rates and outcomes
To assess the impact if any of product hold at study exit on HIV infection and tenofovir resistance
Ancillary Objective
To assess the impact if any of tenofovir gel in preventing sexually transmitted infections including herpes simplex virus type 2 HSV-2 and human papillomavirus HPV infections
Study sites
CAPRISA Vulindlela Clinical Research Site KwaZulu-Natal South Africa
CAPRISA eThekwini Clinical Research Site Durban South Africa
Design Phase IIb two-arm double-blind randomised controlled trial comparing 1 tenofovir gel with a placebo gel
Study Population Sexually active HIV-uninfected women aged 18 to 40 years in South Africa
Study Size 900 women
Treatment Regimen Participants will be provided with a supply of single-use pre-filled applicators according to their randomisation While in the study participants will be asked to apply a first dose of the assigned study product 1 tenofovir gel or placebo gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus They will be advised to use only two doses of gel in a 24-hour period
Study Duration Approximately 30 months in total Accrual will require approximately 14 months and follow-up will continue until 92 incident HIV infections are observed in the study which is expected to occur approximately 16 months after the end of the accrual period
Primary Objective
To evaluate the effectiveness and safety of a candidate vaginal microbicide tenofovir gel when applied intravaginally by women in preventing sexually transmitted HIV infection
Secondary Objectives
To assess the impact if any of tenofovir gel on the incidence rate of deep epithelial disruption
To assess the impact if any of tenofovir gel on viral load in women who become infected with HIV during the trial
To assess tenofovir resistance in HIV seroconvertors in the trial
To ascertain the impact if any of tenofovir gel on pregnancy rates and outcomes
To assess the impact if any of product hold at study exit on HIV infection and tenofovir resistance
Ancillary Objective
To assess the impact if any of tenofovir gel in preventing sexually transmitted infections including herpes simplex virus type 2 HSV-2 and human papillomavirus HPV infections
Study sites
CAPRISA Vulindlela Clinical Research Site KwaZulu-Natal South Africa
CAPRISA eThekwini Clinical Research Site Durban South Africa
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 |
|---|---|---|---|
| PHSC study 9946 | None | None | None |