Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection
NCT ID: NCT02733419
Last Updated: 2016-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2004-12-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enfuvirtide + OB (Not Randomized)
Participants will receive enfuvirtide 90 milligram (mg) twice daily (b.i.d.) and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants not meeting the randomization criteria will receive enfuvirtide 90 mg b.i.d and OB for next 24 weeks (up to Week 52).
Enfuvirtide
Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
Optimized background antiretroviral regimen (OB)
Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs.
Enfuvirtide + OB (Randomized)
Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive enfuvirtide 90 mg b.i.d. and OB for next 24 weeks (up to Week 52).
Enfuvirtide
Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
Optimized background antiretroviral regimen (OB)
Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs.
OB alone (Randomized)
Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive OB alone for next 24 weeks (up to Week 52).
Enfuvirtide
Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
Optimized background antiretroviral regimen (OB)
Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs.
Interventions
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Enfuvirtide
Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
Optimized background antiretroviral regimen (OB)
Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female participants without any risk of pregnancy
* Participants previously treated with drugs of 2 or 3 different antiretroviral classes
* Participants currently on highly active antiretroviral treatment (HAART) for more than 4 weeks and with a plasma viral load between 1,000 and 300,000 copies of HIV-1 ribonucleic acid per milliliter (RNA/mL)
* Participants with the possibility of potentially effective OB without enfuvirtide, consisting to 2 to 5 drugs, at least two of which are active from at least two different antiretroviral classes
* Cluster of differentiation 4 (CD4) cell count greater than (\>) 50 cells/cubic millimeter (mm\^3) at screening
* Participants in whom resistance mutations have been detected in reverse transcriptase and/or protease genes
* Enfuvirtide-naive participants
Exclusion Criteria
* Pregnant or breastfeeding women
* Presence of HIV-2 coinfection
* Participants participating or having participated to another clinical trial during the 30 days prior to selection for this trial
* Participants having previously been treated with enfuvirtide
* Presence active opportunistic infection within 1 month of study entry
* Existence of Grade 4 clinical or laboratory abnormalities
* Cirrhosis or severe hepatic failure
* Uncontrolled diabetes or requiring insulin
* Consumption of alcohol and/or narcotics and/or other substances
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_CHAIR
Hoffmann-La Roche
Locations
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Aix-en-Provence, , France
Angers, , France
Annecy, , France
Argenteuil, , France
Auch, , France
Aulnay-sous-Bois, , France
Avignon, , France
Basse-terre, , France
Besançon, , France
Bobigny, , France
Bordeaux, , France
Bordeaux, , France
Boulogne, , France
Bourg-en-Bresse, , France
Caen, , France
Carpentras, , France
Cayenne, , France
Cayenne, , France
Colmar, , France
Corbeil-Essonnes, , France
Créteil, , France
Fort-de-france, , France
Garches, , France
Kourou, , France
La Roche-sur-Yon, , France
Lagny-sur-Marne, , France
Levallois-Perret, , France
Lyon, , France
Lyon, , France
Mantes-la-Jolie, , France
Marseille, , France
Marseille, , France
Marseille, , France
Marseille, , France
Matoury, , France
Mâcon, , France
Montpellier, , France
Nantes, , France
Nice, , France
Niort, , France
Nîmes, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Pau, , France
Perpignan, , France
Pessac, , France
Pointe à Pitre, , France
Pontoise, , France
Quimper, , France
Rennes, , France
Rouen, , France
Saint-Denis, , France
Saint-Denis, , France
Saint-Dizier, , France
Saint-Pierre, , France
Strasbourg, , France
Suresnes, , France
Toulon, , France
Toulouse, , France
Toulouse, , France
Tours, , France
Valenciennes, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Countries
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Other Identifiers
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ML18242
Identifier Type: -
Identifier Source: org_study_id
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