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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00051831

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

19

Starts

2003-10-01

Expected to finish

2008-05-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infected
• Viral load of 1,000 copies/ml or greater within 60 days prior to study entry
• CD4 count of 100 cells/mm3 or greater within 60 days prior to study entry
• Willing to use acceptable methods of contraception

You may not qualify if…

• Previous treatment with any nucleoside analogue, nonnucleoside reverse transcriptase inhibitor, or fusion inhibitor for longer than 7 days
• Any previous treatment with T-20, lamivudine, or FTC
• HIV-related vaccine within 6 months prior to study entry
• Evidence of HIV seroconversion within 6 months prior to study entry
• Acute AIDS-defining opportunistic infection (OI). Patients who are not clinically stable or who have not been on therapy for the OI for at least 30 days prior to study entry are excluded. Patients who have no evidence of active disease and have been receiving maintenance therapy for AIDS-related OI for at least 30 days are not excluded.
• Systemic chemotherapy within 30 days of study entry or anticipated need for systemic chemotherapy before the end of the study
• Treatment with immune modulators such as systemic steroids, IL-2, alpha interferon, G-CSF, erythropoietin, or any investigational agent within 30 days of study entry
• Allergy to study drugs or their formulations
• Serious illness, substance abuse, or other medical condition that would compromise the patient's ability to participate in the study
• Certain primary resistance HIV mutations
• Pregnancy or breastfeeding

Where it is running

• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Washington U CRS — St Louis, Missouri, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
• Puerto Rico-AIDS CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.