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Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults

NCT00051831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-11-01

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Emtricitabine

Will be administered as one 200-mg capsule orally daily

DRUG

Enfuvirtide

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

DRUG

Ritonavir

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

DRUG

Saquinavir

Will be administered as five hard gel capsules orally twice daily

DRUG

Tenofovir disoproxil fumarate

Will be administered as one 300-mg tablet orally daily

Sponsors & Collaborators

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Joseph J. Eron, Jr., MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2007-12-31
Completion
2008-05-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00051831 on ClinicalTrials.gov