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NCT02847286
To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)
Phase 1 trial testing Dapivirine Ring-004 in HIV- Prevention in 36 participants. Completed in 28 November 2016.
28 November 2016
Quick facts
| Lead sponsor | International Partnership for Microbicides, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 36 |
| Start date | 1 September 2015 |
| Primary completion | 28 November 2016 |
| Estimated completion | 28 November 2016 |
Drugs / interventions tested
- Dapivirine Ring-004 — full drug profile →
- Dapivirine Ring-004 for 28 days along with clotrimazole — full drug profile →
- Clotrimazole (clotrimazole) — full drug profile →
Conditions studied
- HIV- Prevention — all drugs for HIV- Prevention →
Sponsor
International Partnership for Microbicides, Inc. — full company profile →
Who can join
Adults 18 to 45, female only, with HIV- Prevention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004, containing 25 MG of Dapivirine.
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 NCT02847286
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other International Partnership for Microbicides, Inc. trials
Trials by the same sponsor.
- NCT05416021 — Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008 · Phase 1 · completed
- NCT05041699 — PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel · Phase 1 · completed
- NCT03467347 — PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel · Phase 1 · completed
- NCT03234400 — A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings · Phase 1 · completed
- NCT02855346 — PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel · Phase 1 · completed
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 NCT02847286 (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 International Partnership for Microbicides, Inc.
- Last refreshed: 30 August 2017
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/NCT02847286.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing