CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
tenofovir/BI 201335drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01340196
NCT01340196Phase 1Completed
CompareCT.gov

Effect of Multiple Dosing With 240 mg BID BI 201335 on the Steady State Pharmacokinetics of 300mg QD Tenofovir and Effect of Multiple Dosing With 300mg QD Tenofovir on Steady State BI 201335 Pharmacokinetics in Healthy Male and Female Volunteers

Boehringer Ingelheim·interventional·Posted Apr 22, 2011·Updated Jul 31, 2015

In Brief

A Phase 1 clinical trial evaluating tenofovir/BI 201335 for HIV Infections. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2011
Enrollment StartApr 1, 2011
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.2 years ago

Interventions

tenofovir/BI 201335drug

tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22