A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010)

Ross D. Cranston, Craig Hoesley, Alex Carballo-Diéguez, Craig Hendrix, Marla Husnik, Lisa Levy, Wayne Hall, Lydia Soto-Torres, Annalene M. Nel

Research output: Contribution to journalArticle

Abstract

Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor with a favorable safety profile following vaginal application. A penile tolerance study was conducted prior to further development of DPV as a candidate vaginal microbicide. Twenty-four circumcised and 24 uncircumcised (N=48) healthy HIV-negative male participants aged 18 years or older were randomized 2:1:1 to apply DPV 0.05% gel, matched placebo gel, or universal placebo gel, respectively, to their penis once daily for 7 sequential days. The safety, acceptability, and pharmacokinetic profile of DPV 0.05% gel were assessed by the presence of Grade 2 or higher genitourinary adverse events (AEs) and systemic AEs, a behavioral questionnaire, and pharmacokinetic plasma blood draw, respectively, at the final clinic visit (FCV). There were no Grade 2 genitourinary AEs in 47 participants completing the FCV. One participant in the DPV arm failed to attend the FCV. There were 13 AEs reported; all were Grade 1 except one Grade 2 corneal laceration unrelated to study product. Participants liked the gel to a moderate extent, yet 72% reported they would be "very likely" to use a gel like the one they used in the study every time they have intercourse. DPV was detectable in plasma in all 23 DPV arm study participants at the FCV. On average, the circumcised participants' DPV concentrations were 54% of those in uncircumcised participants (p=0.07). Topical seven-day penile application of DPV 0.05% gel was locally and systemically safe, was acceptable to male participants, and resulted in systemic exposure to the drug.

Original languageEnglish (US)
Pages (from-to)184-189
Number of pages6
JournalAIDS Research and Human Retroviruses
Volume30
Issue number2
DOIs
StatePublished - Feb 1 2014

Fingerprint

Gels
Ambulatory Care
Pharmacokinetics
Placebos
Safety
TMC120-R147681
Reverse Transcriptase Inhibitors
Lacerations
Penis
Anti-Infective Agents
HIV
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Immunology
  • Virology
  • Infectious Diseases

Cite this

A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010). / Cranston, Ross D.; Hoesley, Craig; Carballo-Diéguez, Alex; Hendrix, Craig; Husnik, Marla; Levy, Lisa; Hall, Wayne; Soto-Torres, Lydia; Nel, Annalene M.

In: AIDS Research and Human Retroviruses, Vol. 30, No. 2, 01.02.2014, p. 184-189.

Research output: Contribution to journalArticle

Cranston, RD, Hoesley, C, Carballo-Diéguez, A, Hendrix, C, Husnik, M, Levy, L, Hall, W, Soto-Torres, L & Nel, AM 2014, 'A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010)', AIDS Research and Human Retroviruses, vol. 30, no. 2, pp. 184-189. https://doi.org/10.1089/aid.2013.0170
Cranston, Ross D. ; Hoesley, Craig ; Carballo-Diéguez, Alex ; Hendrix, Craig ; Husnik, Marla ; Levy, Lisa ; Hall, Wayne ; Soto-Torres, Lydia ; Nel, Annalene M. / A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010). In: AIDS Research and Human Retroviruses. 2014 ; Vol. 30, No. 2. pp. 184-189.
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