Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016536
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-05-16
Brief Title:
Effects of BufferGel and PRO 20005 Gel in Men
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Male Tolerance Study of BufferGel and PRO 20005 Gel P
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 find out if there are any bad effects when BufferGel or PRO 20005 Gel are applied to the penis of HIV-infected men
Microbicides are products to be used by women for placing into the vagina to prevent passing HIV from 1 person to another during sex Studies have shown 2 investigational microbicides BufferGel and PRO 20005 Gel to be safe and acceptable for women and HIV-negative men It is important to see if the side effects of these products are the same in men as those in women and to see if there is any difference in the side effects between circumcised and uncircumcised men
Microbicides are products to be used by women for placing into the vagina to prevent passing HIV from 1 person to another during sex Studies have shown 2 investigational microbicides BufferGel and PRO 20005 Gel to be safe and acceptable for women and HIV-negative men It is important to see if the side effects of these products are the same in men as those in women and to see if there is any difference in the side effects between circumcised and uncircumcised men
Detailed Description:
Topical microbicides are products designed to prevent the sexual transmission of HIV and other disease pathogens Studies have shown that nonoxynol-9 a detergent microbicide can cause mucosal erosion and ulceration and increased risk of HIV infection Attention has been given to developing non-detergent topical microbicides such as BufferGel and PRO 20005 Gel Studies have shown these products to be safe and acceptable for vaginal use AS PER AMENDMENT 082001 however none of the clinical studies to date have investigated the effects on the penile epithelium and urethral mucosa has been replaced with Phase I trials also have been conducted to assess the safety of BufferGel and PRO 20005 Gel P on the penile epithelium and urethral mucosa In 1 trial HIV-uninfected men applied either PRO 20005 or a gel containing the inactive ingredients of PRO 20005 for 7 days A few patients reported mild symptoms of genital itching tingling irritation dryness discoloration or flaking of the dried gel In a similar trial comparing BufferGel and K-Y Jelly a few patients reported similar symptoms It is important to determine whether the frequency and severity of adverse events experienced by men is comparable to that observed among women It is also important to determine whether these adverse events are similar between circumcised and uncircumcised men
Patients are assigned randomly to 1 of 6 possible sequences of product use Patients complete 3 weeks of nightly product application 7 consecutive nights each of BufferGel PRO 20005 Gel and placebo gel separated by a one-week washout between product-use periods Patients apply the gel to the shaft and glans of the penis at bedtime leave on for a minimum of 6 hours and wash off the next morning Patients maintain a diary of product application and removal side effects and use of other medications Follow-up evaluations including a genital exam and urine testing are performed after each product-use and washout period AS PER AMENDMENT 082001 Digital photographs will be taken of any observed abnormality or normal area that is needed for clinical decision making andor documentation purposes In addition adherence is assessed the patient diary is reviewed and product acceptability questionnaires are administered after each product-use period Patients receive monetary compensation for participation
Patients are assigned randomly to 1 of 6 possible sequences of product use Patients complete 3 weeks of nightly product application 7 consecutive nights each of BufferGel PRO 20005 Gel and placebo gel separated by a one-week washout between product-use periods Patients apply the gel to the shaft and glans of the penis at bedtime leave on for a minimum of 6 hours and wash off the next morning Patients maintain a diary of product application and removal side effects and use of other medications Follow-up evaluations including a genital exam and urine testing are performed after each product-use and washout period AS PER AMENDMENT 082001 Digital photographs will be taken of any observed abnormality or normal area that is needed for clinical decision making andor documentation purposes In addition adherence is assessed the patient diary is reviewed and product acceptability questionnaires are administered after each product-use period Patients receive monetary compensation for participation
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 |
|---|---|---|---|
| 10693 | REGISTRY | DAIDS ES | None |