CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Emtricitabine +4 moredrug
Likely dose
Enfuvirtide 1.0 mLfrom 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/NCT00051831
NCT00051831N/ACompleted

A Pilot Study to Measure the Clearance of Replication-Competent HIV-1 in Resting Memory CD4+ Cells in HIV-1-Infected Subjects Who Receive Enfuvirtide Plus Oral Combination Antiretroviral Therapy

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 20, 2003·Updated Nov 1, 2021

In Brief

A clinical study evaluating Emtricitabine, Enfuvirtide, and 3 other interventions for HIV Infections. Completed, enrolled 19 participants across 7 sites in 2 countries.

Detailed Summary

HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 20, 2003
Enrollment StartOct 1, 2003
Primary CompletionDec 1, 2007
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 23.4 years ago

Interventions

Emtricitabinedrug

Will be administered as one 200-mg capsule orally daily

Enfuvirtidedrug

Will be administered as a 90-mg (1.0 mL) subcutaneous injection twice daily

Ritonavirdrug

Will be administered as one 100-mg capsule orally twice daily

Saquinavirdrug

Will be administered as five hard gel capsules orally twice daily

Tenofovir disoproxil fumaratedrug

Will be administered as one 300-mg tablet orally daily