Randomized Trial of Clinical Safety of Daily Oral Tenofovir Disoproxil Fumarate Among HIV-Uninfected Men Who Have Sex With Men in the United States
- 1 September 2013
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in JAIDS Journal of Acquired Immune Deficiency Syndromes
- Vol. 64 (1), 79-86
- https://doi.org/10.1097/qai.0b013e31828ece33
Abstract
To evaluate the clinical safety of daily tenofovir disoproxil fumarate (TDF) among HIV-negative men who have sex with men. Randomized, double-blind, placebo-controlled trial. Participants were randomized 1:1:1:1 to immediate or delayed study drug (TDF, 300 mg orally per day, or placebo). Four hundred healthy HIV-uninfected men who have sex with men reporting anal sex with another man within the previous 12 months enrolled in Atlanta, Boston, and San Francisco. HIV serostatus, clinical and laboratory adverse events (AEs), adherence (pill count, Medication Event Monitoring System, and self-report), and sexual and other sociobehavioral data were assessed at 3-month intervals for 24 months. Primary outcomes were clinical safety, assessed by incidence of AEs and laboratory abnormalities. Study drug was initiated by 373 (93%) participants (186 TDF and 187 placebo), of whom 325 (87%) completed the final study visit. Of 2428 AEs reported among 334 (90%) participants, 2366 (97%) were mild or moderate in severity. Frequencies of commonly reported AEs did not differ significantly between TDF and placebo arms. In multivariable analyses, back pain was more likely among TDF recipients (P = 0.04); these reports were not associated with documented fractures or other objective findings. There were no grade ≥3 creatinine elevations; grades 1 and 2 creatinine increases were not associated with TDF receipt. Estimated percentage of study drug doses taken was 92% by pill count and 77% by Medication Event Monitoring System. Seven seroconversions occurred: 4 on placebo and 3 among delayed arm participants not yet on study drug. Daily oral TDF was well tolerated, with reasonable adherence. No significant renal concerns were identified.Keywords
This publication has 26 references indexed in Scilit:
- Penetration of Tenofovir and Emtricitabine in Mucosal Tissues: Implications for Prevention of HIV-1 TransmissionScience Translational Medicine, 2011
- Bone Mineral Density in HIV-Negative Men Participating in a Tenofovir Pre-Exposure Prophylaxis Randomized Clinical Trial in San FranciscoPLOS ONE, 2011
- Estimated HIV Incidence in the United States, 2006–2009PLOS ONE, 2011
- Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with MenThe New England Journal of Medicine, 2010
- Tolerability of HIV postexposure prophylaxis with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulationAIDS, 2010
- Systemic Administration of Antiretrovirals Prior to Exposure Prevents Rectal and Intravenous HIV-1 Transmission in Humanized BLT MicePLOS ONE, 2010
- Intermittent Prophylaxis with Oral Truvada Protects Macaques from Rectal SHIV InfectionScience Translational Medicine, 2010
- Prevention of Rectal SHIV Transmission in Macaques by Daily or Intermittent Prophylaxis with Emtricitabine and TenofovirPLoS Medicine, 2008
- Antiretroviral drug exposure in the female genital tract: implications for oral pre- and post-exposure prophylaxisAIDS, 2007
- The Safety and Efficacy of Tenofovir DF in Combination with Lamivudine and Efavirenz Through 6 Years in Antiretroviral-Naïve HIV-1—Infected PatientsHIV Research & Clinical Practice, 2007