Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262106
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2005-12-05
Brief Title:
Trial to Evaluate PRO 20005 Gels for the Prevention of Vaginally Acquired HIV Infection
Sponsor:
Endo Pharmaceuticals
Organization:
Endo Pharmaceuticals
Study Overview
Official Title:
An International Multi-centre Randomised Double-blind Placebo-controlled Trial to Evaluate the Efficacy and Safety of 05 and 2 PRO 20005 Gels for the Prevention of Vaginally Acquired HIV Infection
Status:
COMPLETED
Status Verified Date:
2012-09
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:
The objective of the study is to determine the efficacy and safety of 05 and 2 PRO 20005 gels compared to placebo in preventing vaginally acquired HIV infection
Detailed Description:
The HIV pandemic continues with an estimated 13000 new infections each day the vast majority of which are acquired through heterosexual intercourse Although consistent and correct use of condoms by men remains the most effective form of protection from heterosexually acquired HIV women are not always able to negotiate condom use An effective prophylactic vaccine remains a key objective but development is slow because of virus variability and difficulty in determining the immunological correlates of protection Vaginal microbicides are being developed in response to the urgent need for an HIV prevention method that women can control Licensed spermicides containing nonoxynol-9 N-9 which has potent anti-HIV activity in vitro were the first products to be investigated as potential microbicides However the association of N-9 and other products belonging to this class surfactants with genital epithelial disruption histologically determined genital inflammation and reduction in populations of vaginal lactobacilli led to concerns that their use could enhance the risk of HIV transmission Early Phase 3 studies of N-9 products yielded conflicting results but more recently a multicenter randomized placebo-controlled trial of a low dose N-9 formulation demonstrated an increased incidence of HIV infection in the N-9 group compared to placebo These findings have intensified efforts to develop agents with a more favorable toxicity profile At least four of these have entered trials to assess effectiveness in preventing vaginally acquired HIV infection Buffer Gel Carraguard cellulose sulfate and PRO 20005 Gel Protocol MDP 301 describes a randomized placebo-controlled trial design to explore the safety and efficacy of two concentrations of PRO 20005 Gel
Participant recruitment and follow-up is complete Between October 2005 and August 2008 9404 eligible sexually active HIV-uninfected women were enrolled at six or more sites in Africa Up until February 2008 participants were randomly assigned to 05 or 2 PRO 20005 Gel treatment arms or a placebo gel arm Following a recommendation by the Independent Data Monitoring Committee that the 2 PRO20005 Gel treatment arm should not continue as there was no more than a small chance of demonstrating benefit participants enrolled after February 13 2008 were randomly assigned to the 05 PRO 20005 gel treatment arm or placebo arm Participants were instructed to apply a single dose of study gel 1 hour or less before every act of vaginal intercourse using a single-use pre-filled applicator Participants also receive risk-reduction counseling and condoms and STD testing Most study participants were followed for 12 months A cohort of sero-discordant couples enrolled in Uganda was followed for up to 24 months
The primary efficacy outcome measure is acquisition of HIV infection at the 12 month time point Secondary outcomes include measures of HIV infection at the 6 9 and more than 12 month time points infection by HSV-2 Neisseria gonorrhoeae Chlamydia trachomatis and adverse events
Participant recruitment and follow-up is complete Between October 2005 and August 2008 9404 eligible sexually active HIV-uninfected women were enrolled at six or more sites in Africa Up until February 2008 participants were randomly assigned to 05 or 2 PRO 20005 Gel treatment arms or a placebo gel arm Following a recommendation by the Independent Data Monitoring Committee that the 2 PRO20005 Gel treatment arm should not continue as there was no more than a small chance of demonstrating benefit participants enrolled after February 13 2008 were randomly assigned to the 05 PRO 20005 gel treatment arm or placebo arm Participants were instructed to apply a single dose of study gel 1 hour or less before every act of vaginal intercourse using a single-use pre-filled applicator Participants also receive risk-reduction counseling and condoms and STD testing Most study participants were followed for 12 months A cohort of sero-discordant couples enrolled in Uganda was followed for up to 24 months
The primary efficacy outcome measure is acquisition of HIV infection at the 12 month time point Secondary outcomes include measures of HIV infection at the 6 9 and more than 12 month time points infection by HSV-2 Neisseria gonorrhoeae Chlamydia trachomatis and adverse events
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 |
|---|---|---|---|
| ISRCTN64716212 | None | None | None |