CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Intermitent Dosingdrug
Likely dose
Efavirenz 600 mg, tenofovir 300 mg, emtricitabine 200 mg daily (5 days on/2 days off)AI-extracted
Key inclusion· 4
  • Age 18 years or older
  • CD4 count ≥200 cells/μL
  • Viral load <50 copies/mL (undetectable)
  • On efavirenz + tenofovir + (lamivudine or emtricitabine) for ≥90 days prior to screening
Key exclusion· 3
  • Detectable HIV RNA on ultrasensitive assay within 90 days before screening
  • Prior evidence of intermediate or high-level resistance to efavirenz, tenofovir, or cytidine analogues
  • Hepatitis B infection

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

Search/NCT00414635
NCT00414635Phase 4Completed

A Randomized Controlled Trial of a Weekly Schedule of Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment (5/2 Intermittent Treatment Schedule) Versus Continuous Treatment in Individuals With Virologic Suppression on This Combination

Community Research Initiative of New England·interventional·Posted Dec 21, 2006·Updated Sep 25, 2017

In Brief

A Phase 4 clinical trial evaluating Intermitent Dosing for HIV Infections. Completed, enrolled 60 participants across 7 sites.

Detailed Summary

For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.

Study Details

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

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2006
Enrollment StartAug 1, 2006
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.5 years ago

Interventions

Intermitent Dosingdrug

Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. .