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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: AIDS Clinical Trials Group
• Treatments: Emtricitabine; Enfuvirtide; Ritonavir; Saquinavir; Tenofovir

Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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