A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience
INTENSE
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
1 other identifier
interventional
47
10 countries
39
Brief Summary
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hiv-infections
Started Nov 2005
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
September 2, 2011
CompletedAugust 13, 2015
July 1, 2015
2 years
June 14, 2007
March 22, 2011
July 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase
Participants whose viral load achieved suppression (HIV-1 RNA \< 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.
From Baseline 1 to Week 28
Secondary Outcomes (13)
Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase
Baseline 1 until Week 28.
Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase
From Baseline 1 to Week 28
Change From Baseline to Week 24 in Viral Load
Baseline and Week 24
Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts
Baseline and Week 24
Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks
Week 48
- +8 more secondary outcomes
Study Arms (2)
ENF + HAART
EXPERIMENTALParticipants received Enfuvirtide (ENF) 90 mg administered by subcutaneous injection twice a day for up to 48 weeks in addition to an oral highly active antiretroviral treatment (HAART) regimen for up to 48 weeks.
HAART
ACTIVE COMPARATORParticipants received an oral highly active antiretroviral treatment (HAART) regimen, consisting of 3-5 antivirals for up to 48 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- HIV-1 infected adults \>=18 years of age;
- currently on antiretroviral (ARV) therapy;
- previously treated with 2 or 3 different antiretroviral classes;
- HIV-1 Ribonucleic acid (RNA) \>=1,000 copies/mL;
- Cluster differentiation antigen four (CD4) lymphocyte count \>=200 cells/mm\^3;
- females of childbearing potential must be willing to use a reliable form of effective barrier contraception for the duration of the study and for 30 days after the last dose of study drug.
You may not qualify if:
- history of prior use of enfuvirtide or T-1249;
- women who are pregnant, breastfeeding or planning to become pregnant during the study;
- active, untreated opportunistic infection;
- patients on treatment interruption, or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons either than toxicity management.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Cleveland, Ohio, 44109, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Vancouver, British Columbia, V6Z 2C7, Canada
Unknown Facility
Le Kremlin-Bicêtre, 94275, France
Unknown Facility
Nantes, 44035, France
Unknown Facility
Paris, 75018, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Villeneuve-sur-Lot, 47307, France
Unknown Facility
Berlin, 12157, Germany
Unknown Facility
Bonn, 53127, Germany
Unknown Facility
Erlangen, 91054, Germany
Unknown Facility
Frankfurt am Main, 60596, Germany
Unknown Facility
Ramat Gan, 52662, Israel
Unknown Facility
Bagno a Ripoli, 50011, Italy
Unknown Facility
Bari, 70100, Italy
Unknown Facility
Brescia, 25123, Italy
Unknown Facility
Milan, 20127, Italy
Unknown Facility
Milan, 20157, Italy
Unknown Facility
Roma, 00149, Italy
Unknown Facility
Roma, 00185, Italy
Unknown Facility
Mexico City, 14000, Mexico
Unknown Facility
Amsterdam, 1105 AZ, Netherlands
Unknown Facility
Tilburg, 5022 GC, Netherlands
Unknown Facility
Barcelona, 08026, Spain
Unknown Facility
Barcelona, 08036, Spain
Unknown Facility
Barcelona, 08370, Spain
Unknown Facility
Barcelona, 08901, Spain
Unknown Facility
Cadiz, 11009, Spain
Unknown Facility
Córdoba, 14004, Spain
Unknown Facility
Donostia / San Sebastian, 20014, Spain
Unknown Facility
Huelva, 21005, Spain
Unknown Facility
Madrid, 28034, Spain
Unknown Facility
Madrid, 28041, Spain
Unknown Facility
Madrid, 28046, Spain
Unknown Facility
Málaga, 29010, Spain
Unknown Facility
Seville, 41013, Spain
Unknown Facility
Valencia, 46014, Spain
Unknown Facility
Zurich, 8091, Switzerland
Related Publications (1)
Clotet B, Capetti A, Soto-Ramirez LE, Gatell JM, Rowell L, Salgo M, Schapiro JM. A randomized, controlled study evaluating an induction treatment strategy in which enfuvirtide was added to an oral, highly active antiretroviral therapy regimen in treatment-experienced patients: the INTENSE study. J Antimicrob Chemother. 2008 Dec;62(6):1374-8. doi: 10.1093/jac/dkn377. Epub 2008 Sep 8.
PMID: 18782780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2007
First Posted
June 15, 2007
Study Start
November 1, 2005
Primary Completion
November 1, 2007
Study Completion
April 1, 2008
Last Updated
August 13, 2015
Results First Posted
September 2, 2011
Record last verified: 2015-07