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NCT00016536
Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)
Phase 1 trial testing Naphthalene 2-sulfonate polymer in HIV Infections in 24 participants. Completed in 1 May 1997.
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Design | crossover |
| Primary purpose | prevention |
| Enrollment | 24 |
| Estimated completion | 1 May 1997 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Naphthalene 2-sulfonate polymer — full drug profile →
- Carbopol polymer — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
18 and older, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00016536
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00016536 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 28 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00016536.
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