drugset / Trial / NCT01768962
Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel
Phase 1
Completed
14 enrolled
CONRAD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabNational Institute of Mental Health (NIMH) · collab
RandomizedCrossoverOpen-labelOther
Summary
To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin (TFV RG) 1% gel after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use
Timeline
- Start
- 2014-04
- Primary completion
- 2014-12
- Completion
- 2014-12
Publications
- Background Justman JE, Nair GL, Hendrix CW, Piper JM, Marzinke MA, Dai JY, Pan Z, Galaska B, Levy L, Schwartz JL, Balar B, Kunjara Na Ayudhya RP, Mushamiri I, McGowan I, Dezzutti CS; MTN-014 Study Team. Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing. J Acquir Immune Defic Syndr. 2018 Jun 1;78(2):175-182. doi: 10.1097/QAI.0000000000001655.
- Hughes SM, Calienes FL, Levy CN, Pandey U, Gornalusse GG, Cranston RD, Lama JR, Pickett J, Brand RM, Hendrix CW, Marzinke MA, Dai JY, Balar B, Justman JE, Nair G, Berard AR, Birse K, Noel-Romas L, Mayer KH, Stekler JD, Mackelprang R, Burgener AD, McGowan I, Cameron CM, Cameron MJ, Woodrow KA, Hladik F. Mucosal tenofovir 1% gel stimulates cell proliferation and type I/III interferon pathways. Microbiol Spectr. 2026 Mar 23;14(5):e0168025. doi: 10.1128/spectrum.01680-25. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tenofovir | Small molecule | 1 % | Other |
Indications
No indication recorded.