At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 47 enrolled
Drug / intervention
Enfuvirtide +1 moredrug
Likely dose
Enfuvirtide 90 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Enfuvirtide and Highly active antiretroviral treatment (HAART) for HIV Infections. Completed, enrolled 47 participants across 39 sites in 10 countries.
Detailed Summary
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesCanada, France, Germany, Israel, Italy, Mexico, Netherlands, Spain, Switzerland, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedJun 2007
Primary CompletionNov 2007
Study CompletionApr 2008
TodayJul 2026
First PostedJun 15, 2007
Enrollment StartNov 1, 2005
Primary CompletionNov 1, 2007
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.0 years ago
Interventions
Enfuvirtidedrug
90 mg subcutaneous injection twice a day
Highly active antiretroviral treatment (HAART)drug
An oral HAART regimen of 3-5 antiretrovirals was chosen by the physician and patient, based on the patient's prior treatment history and genotypic antiretroviral resistance testing.