Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111943
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-05-26
Brief Title:
Safety and Acceptability of a Vaginal Microbicide
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1 Tenofovir 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 determine the safety and acceptability of a vaginal microbicide in HIV uninfected sexually active women
Study hypothesis The vaginal microbicide 1 tenofovir will be safe and well tolerated in HIV uninfected women who are in good general health
Study hypothesis The vaginal microbicide 1 tenofovir will be safe and well tolerated in HIV uninfected women who are in good general health
Detailed Description:
While the male condom is effective in preventing sexual transmission of HIV its use is hampered by deeply rooted cultural and social barriers About half of all HIV infections worldwide occur in women yet the only available female-controlled method of HIV prevention is the female condom Alternative prevention tools such as vaginal microbicides are urgently needed to slow the rapid spread of heterosexual HIV infection
This study will last 24 weeks with an additional 10 weeks of follow-up for participants with chronic hepatitis B virus HBV infection Participants will be randomly assigned to one of four arms Arm A participants will insert a vaginal tenofovir 1 gel two hours prior to vaginal intercourse for a maximum of two daily applications Arm B participants will insert a vaginal placebo gel two hours prior to vaginal intercourse for a maximum of two daily applications Arm C participants will insert a vaginal tenofovir 1 gel once daily at bedtime or during the longest period of daily rest Arm D participants will insert a vaginal placebo gel once daily at bedtime or during the longest period of daily rest
A medical and menstrual history update pregnancy test HIV and sexually transmitted infections STI risk reduction counseling and interview to assess behaviors toward vaginal gel use will occur during all study visits HIVSTI counseling and testing urinalysis and blood collection will occur at study entry and at Week 24 Pelvic exam with colposcopy and vaginal swab collection will occur at study entry and Weeks 4 12 and 24 For participants with chronic HBV additional blood will be collected to monitor hepatitis B infection at study entry and Weeks 12 24 28 32 and 36
This study will last 24 weeks with an additional 10 weeks of follow-up for participants with chronic hepatitis B virus HBV infection Participants will be randomly assigned to one of four arms Arm A participants will insert a vaginal tenofovir 1 gel two hours prior to vaginal intercourse for a maximum of two daily applications Arm B participants will insert a vaginal placebo gel two hours prior to vaginal intercourse for a maximum of two daily applications Arm C participants will insert a vaginal tenofovir 1 gel once daily at bedtime or during the longest period of daily rest Arm D participants will insert a vaginal placebo gel once daily at bedtime or during the longest period of daily rest
A medical and menstrual history update pregnancy test HIV and sexually transmitted infections STI risk reduction counseling and interview to assess behaviors toward vaginal gel use will occur during all study visits HIVSTI counseling and testing urinalysis and blood collection will occur at study entry and at Week 24 Pelvic exam with colposcopy and vaginal swab collection will occur at study entry and Weeks 4 12 and 24 For participants with chronic HBV additional blood will be collected to monitor hepatitis B infection at study entry and Weeks 12 24 28 32 and 36
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 |
|---|---|---|---|
| 10145 | REGISTRY | DAIDS ES | None |