PK/PD of Single Dose Dapivirine Vaginal Film
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|ClinicalTrials.gov Identifier: NCT01924091|
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : September 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pharmaokinetics||Drug: Dapivirine gel Drug: Dapivirine film||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of the Pharmacokinetics and Pharmacodynamics of Single Dose Dapivirine Vaginal Gel and Film Formulation|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Dapivirine Gel
As outlined above, multiple gel formulations of dapivirine have been developed for vaginal use.
Three formulations, Dapivirine Gel-001 (Gel-001), Dapivirine Gel-002 (Gel-002), and Dapivirine Gel 4750 (Gel 4750) are no longer in development. Dapivirine Gel 4789, which has been tested in one clinical trial (IPM012), and Dapivirine Gel 4759 were recently evaluated in clinical trials, IPM 014A and IPM 020. This trial will use Dapivirine Gel 4759.
Drug: Dapivirine gel
Experimental: Dapivirine Film
Dapivirine film is formulated in a polyvinyl alcohol (PVA) based vaginal film containing hydroxypropyl methyl cellulose (HPMC) E5 (5 cp), polyethylene glycol 8000 (PEG), propylene glycol, and glycerin. PVA constituted 55.1% (w/w) of the film. The target loading dose for the film is 1.25 mg dapivirine per film based on phase I studies using dapivirine gels at concentrations of 0.01%, 0.02% and 0.05%30-33. The quantity of gel administered in these studies was 2.5 mL. Consequently the administered dose corresponds to 0.25, 0.5 and 1.25 mg dapivirine, respectively.
Drug: Dapivirine film
- Dapivirine concentrations in plasma [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924091
|Principal Investigator:||Craig Hendrix, MD||John's Hopkins University|