CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 400 enrolled
Drug / intervention
tenofovir disoproxil fumarate +1 moredrug
Likely dose
Tenofovir disoproxil fumarate dailyAI-extracted
Key inclusion· 6
  • ✓Biologic male, age 18–60 years
  • ✓HIV-1 negative by FDA-approved whole blood rapid EIA at screening and enrollment
  • ✓Any anal sex with a man in the last 12 months
  • ✓Adequate renal function: creatinine clearance ≥70 mL/min
Key exclusion· 11
  • ✕Active untreated syphilis
  • ✕Uncontrolled hypertension (BP >160/100 mmHg)
  • ✕Mutually monogamous for >1 year with known HIV-negative partner
  • ✕History of chronic renal disease, osteoporosis, osteomalacia, or osteopenia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00131677
NCT00131677Phase 2Completed
CompareCT.gov

Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men

Centers for Disease Control and Prevention·interventional·Posted Aug 19, 2005·Updated Mar 10, 2014

In Brief

A Phase 2 clinical trial evaluating tenofovir disoproxil fumarate and placebo for HIV Infection. Completed, enrolled 400 participants across 3 sites.

Detailed Summary

The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesUnited States
CollaboratorsSan Francisco Department of Public Health, AIDS Research Consortium of Atlanta

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 19, 2005
Enrollment StartFeb 1, 2005
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.9 years ago

Interventions

tenofovir disoproxil fumaratedrug

study product taken daily

placebodrug

study product taken daily