Safety and Acceptability of the Anti-Microbe Vaginal Gel, PMPA Gel
|First Received Date ICMJE||December 13, 2001|
|Last Updated Date||February 16, 2012|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00028132 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Safety and Acceptability of the Anti-Microbe Vaginal Gel, PMPA Gel|
|Official Title ICMJE||Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel|
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 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 05/29/02: 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 05/29/02: 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 Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Drug: Tenofovir|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
All female participants may be eligible for this study if they:
Female participants may not be eligible for this study if they:
|Ages||18 Years to 45 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00028132|
|Other Study ID Numbers ICMJE||HPTN 050, 10696|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute of Allergy and Infectious Diseases (NIAID)|
|Verification Date||February 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP