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Phase IIIb/IV Randomized, Controlled Study Evaluating an Intensification Treatment Strategy of Adding Enfuvirtide (ENF) to an Oral Highly Active AntiRetroviral Therapy (HAART) in Treatment Experienced Patients
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.
This study consisted of two phases. In the Induction phase patients were randomized at Baseline 1 (BL1) in a 1:2 ratio to receive: * I1: HAART or * I2: Enfuvirtide (90 mg twice a day) + HAART. Participants who achieved viral suppression \< 50 copies/mL by week 24, confirmed by week 28 or earlier, qualified to enter the Maintenance Phase which started at Baseline 2 (BL2), four weeks after confirmation of response. The Maintenance Phase consisted of three treatment groups: * M1: HAART continued (patients from I1) Patients on ENF+HAART (I2) were re-randomized (at a 1:1 ratio) at BL2 to: * M2: Enfuvirtide stopped and HAART continued * M3: Enfuvirtide + HAART continued. The duration of the Maintenance Phase was from BL2 up to 48 weeks after BL1. BL2 could start at the earliest at Week 12 and at the latest Week 32.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cleveland, Ohio, United States
Austin, Texas, United States
Dallas, Texas, United States
Vancouver, British Columbia, Canada
Le Kremlin-Bicêtre, France
Nantes, France
Paris, France
Poitiers, France
Villeneuve-sur-Lot, France
Berlin, Germany
Start Date
November 1, 2005
Primary Completion Date
November 1, 2007
Completion Date
April 1, 2008
Last Updated
August 13, 2015
47
ACTUAL participants
Enfuvirtide
DRUG
Highly active antiretroviral treatment (HAART)
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330