Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028132
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-12-13
Brief Title:
Safety and Acceptability of the Anti-Microbe Vaginal Gel PMPA Gel
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel
Status:
COMPLETED
Status Verified Date:
2021-10
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 purpose of this study is to evaluate the PMPA gel which kills microbes in HIV-infected and HIV-uninfected women
The majority of new HIV infections occur through heterosexual contact A product that stops or slows the replication of HIV during sexual contact is needed At present there are no products that are completely effective PMPA gel also known as tenofovir is an anti-microbe agent that may fight against sexual transmission of HIV and other sexually transmitted diseases STDs It is applied to the vagina and gives women the ability to control their disease-prevention activity
The majority of new HIV infections occur through heterosexual contact A product that stops or slows the replication of HIV during sexual contact is needed At present there are no products that are completely effective PMPA gel also known as tenofovir is an anti-microbe agent that may fight against sexual transmission of HIV and other sexually transmitted diseases STDs It is applied to the vagina and gives women the ability to control their disease-prevention activity
Detailed Description:
The majority of new HIV infections are transmitted through heterosexual contact Currently there is no single product that is completely efficacious in preventing initial HIV infection through vaginal transmission Thus the development of a topical product which could block local virus replication once infection has occurred is needed Topical microbicides are designed to prevent the sexual transmission of HIV and other disease pathogens Potentially they can be applied vaginally to prevent both male-to-female and female-to-male transmission They also offer a female-controlled option PMPA gel has shown some activity against HIV and STD pathogens in in vitro and in vivo laboratory studies
Participants undergo eligibility screening tests which include a general physical exam a pelvic exam a urine pregnancy test urinalysis HIV and STD testing and counseling and hematology liver and renal function tests For HIV-infected participants a CD4 cell count is performed and specimens are collected for quantitation of HIV viral load in plasma and cervico-vaginal fluids AS PER AMENDMENT 052902 and for HIV resistance genotyping PMPA gel is evaluated among 4 types of women distributed into 7 cohorts All participants apply PMPA gel intravaginally for 14 consecutive intramenstrual days The dose and frequency of application is escalated across cohorts Cohorts A1 through A4 consist of HIV-uninfected abstinent women who use different doses of PMPA gel once or twice daily Cohort B includes HIV-uninfected women who are sexually active Cohorts C and D consist of HIV-infected women who are abstinent or sexually active respectively Cohorts B C and D use the highest practical dose frequency The male partners of sexually active participants undergo HIV and STD testing and counseling as well as an optional genital exam and a post-regimen interview Participants keep a daily record of when doses are taken and of any adverse effects Pelvic exams and hematology liver and renal function tests and CD4 cell counts AS PER AMENDMENT 052902 and resistance genotyping in HIV-infected participants are performed at follow-up visits After the regimen is complete participants participate in group interviews to discuss adverse effects adherence to and general perception of PMPA gel
The first 6 participants in Cohorts A2 B and C take part in a pharmacokinetic PK study of PMPA gel Serum collection and PK analysis are performed at different time intervals during 2 study visits
Participants undergo eligibility screening tests which include a general physical exam a pelvic exam a urine pregnancy test urinalysis HIV and STD testing and counseling and hematology liver and renal function tests For HIV-infected participants a CD4 cell count is performed and specimens are collected for quantitation of HIV viral load in plasma and cervico-vaginal fluids AS PER AMENDMENT 052902 and for HIV resistance genotyping PMPA gel is evaluated among 4 types of women distributed into 7 cohorts All participants apply PMPA gel intravaginally for 14 consecutive intramenstrual days The dose and frequency of application is escalated across cohorts Cohorts A1 through A4 consist of HIV-uninfected abstinent women who use different doses of PMPA gel once or twice daily Cohort B includes HIV-uninfected women who are sexually active Cohorts C and D consist of HIV-infected women who are abstinent or sexually active respectively Cohorts B C and D use the highest practical dose frequency The male partners of sexually active participants undergo HIV and STD testing and counseling as well as an optional genital exam and a post-regimen interview Participants keep a daily record of when doses are taken and of any adverse effects Pelvic exams and hematology liver and renal function tests and CD4 cell counts AS PER AMENDMENT 052902 and resistance genotyping in HIV-infected participants are performed at follow-up visits After the regimen is complete participants participate in group interviews to discuss adverse effects adherence to and general perception of PMPA gel
The first 6 participants in Cohorts A2 B and C take part in a pharmacokinetic PK study of PMPA gel Serum collection and PK analysis are performed at different time intervals during 2 study visits
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 |
|---|---|---|---|
| 10696 | REGISTRY | DAIDS ES | None |