Overview

This trial is active, not recruiting.

Condition hiv infections
Treatment enfuvirtide-intensified haart
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Start date March 2003
End date December 2005
Trial size 20 participants
Trial identifier NCT00102934, 5R21-AI055273-02, 5R21AI055273-02, Protocol 834

Summary

Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most patients do well if they continue taking them. The purpose of this study is to test the effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection in adults who have virus resistant to multiple drugs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive enfuvirtide for 6 months
enfuvirtide-intensified haart T-20
90 mg tablet taken orally twice daily

Primary Outcomes

Measure
HIV viral load
time frame: Throughout study

Secondary Outcomes

Measure
Frequency of HIV-specific T cells
time frame: Thoughout study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - HIV viral load of more than 1000 copies/ml - On stable antiretroviral therapy - Have multidrug resistance Exclusion Criteria: - Require immunomodulatory drugs

Additional Information

Official title Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus
Principal investigator Steven G. Deeks, MD
Description While an HIV infected patient is taking highly active antiretroviral therapy (HAART), drug-resistant HIV may emerge; however, it has been observed that HIV viral loads while on HAART are usually lower than baseline levels. Expansion of the T cell population during early HAART may explain this phenomenon. It is hoped that a short but aggressive HAART regimen to treatment-experienced patients who have drug-resistant virus will produce immune cells that will better control drug-resistant virus. This study will determine if a 6-month HAART regimen intensified by enfuvirtide (T-20) is effective in eliciting a stronger immune response against drug-resistant virus. This study will last 48 weeks. All participants will receive T-20 as part of a HAART intensification regimen; HAART other than T-20 will not be provided by the study. There will be 17 study visits. Prior to beginning treatment intensification, participants will have weekly study visits for three weeks. Once treatment intensification has started, participants will be followed weekly for four weeks, then weekly for four weeks after treatment intensification, then monthly thereafter. Blood collection will occur at each visit.
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).