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NCT05416021
Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008
Phase 1 trial testing dapivirine in HIV Infections in 124 participants. Completed in 2 July 2024.
2 April 2024
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 | 124 |
| Start date | 1 August 2022 |
| Primary completion | 2 April 2024 |
| Estimated completion | 2 July 2024 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- dapivirine — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
International Partnership for Microbicides, Inc. — full company profile →
Who can join
Adults 18 to 45, female only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants
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 NCT05416021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HIV Infections
Currently open trials in the same condition.
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- NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
- NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting
Other International Partnership for Microbicides, Inc. trials
Trials by the same sponsor.
- 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
- NCT02858037 — Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women · Phase 3 · 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 NCT05416021 (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: 3 July 2024
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/NCT05416021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing