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NCT00016536 · ClinicalTrials.gov registry record · Phase 1
Effects of BufferGel and PRO 2000/5 Gel in Men
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00016536 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants.
The verdict
NCT00016536, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if there are any bad effects when BufferGel or PRO 2000/5 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 2000/5 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.
Interventions
- DRUG Naphthalene 2-sulfonate polymer
- DRUG Carbopol polymer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Est. Completion | 1997-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00016536
The ClinicalTrials.gov registry entry for NCT00016536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Naphthalene 2-sulfonate polymer is the first listed.
NCT00016536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00016536 about?
NCT00016536 is a clinical study titled "Effects of BufferGel and PRO 2000/5 Gel in Men". The purpose of this study is to find out if there are any bad effects when BufferGel or PRO 2000/5 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 sho...
What is the current status of trial NCT00016536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. Estimated completion is 1997-05.
What interventions are being tested in trial NCT00016536?
The interventions under investigation include: Naphthalene 2-sulfonate polymer (DRUG), Carbopol polymer (DRUG).
Who is sponsoring clinical trial NCT00016536?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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