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
NCT ID: NCT00487188
Last Updated: 2015-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
47 participants
INTERVENTIONAL
2005-11-30
2008-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ENF + HAART
Participants 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.
Enfuvirtide
90 mg subcutaneous injection twice a day
Highly active antiretroviral treatment (HAART)
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.
HAART
Participants received an oral highly active antiretroviral treatment (HAART) regimen, consisting of 3-5 antivirals for up to 48 weeks.
Highly active antiretroviral treatment (HAART)
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.
Interventions
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Enfuvirtide
90 mg subcutaneous injection twice a day
Highly active antiretroviral treatment (HAART)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Bonn, , Germany
Erlangen, , Germany
Frankfurt am Main, , Germany
Ramat Gan, , Israel
Bagno a Ripoli, , Italy
Bari, , Italy
Brescia, , Italy
Milan, , Italy
Milan, , Italy
Roma, , Italy
Roma, , Italy
Mexico City, , Mexico
Amsterdam, , Netherlands
Tilburg, , Netherlands
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Cadiz, , Spain
Córdoba, , Spain
Donostia / San Sebastian, , Spain
Huelva, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Seville, , Spain
Valencia, , Spain
Zurich, , Switzerland
Countries
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References
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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.
Other Identifiers
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MV18406
Identifier Type: -
Identifier Source: org_study_id
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