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
Open-label, Randomised and Multi-center Study Evaluating the Efficacy and Safety of an Optimised Background Antiretroviral Regimen (OB) Compared to OB Associated With Enfuvirtide in Previously Treated HIV-1 Infected Patients in Virological Success After a 28-week Induction Treatment With Enfuvirtide Plus OB
1 other identifier
interventional
84
1 country
71
Brief Summary
This is an open-label, randomized and multi-center study to compare the efficacy and safety of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with HIV-1 infection. Participants will receive an initial 28 week induction treatment with enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to (\</=) 400 copies/milliliter (mL) at Week 16 and less than (\<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hiv-infections
Started Dec 2004
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 5, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedApril 11, 2016
April 1, 2016
3.2 years
April 5, 2016
April 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52
Week 52
Secondary Outcomes (13)
Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL)
Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52
Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score
Weeks 2, 4, 8, and 24
Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score
Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal
Change from baseline in viral load
Baseline up to Week 52 or premature withdrawal
Proviral deoxyribonucleic acid (DNA) level
Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal
- +8 more secondary outcomes
Study Arms (3)
Enfuvirtide + OB (Not Randomized)
EXPERIMENTALParticipants 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 + OB (Randomized)
EXPERIMENTALParticipants 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).
OB alone (Randomized)
EXPERIMENTALParticipants 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).
Interventions
Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
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.
Eligibility Criteria
You may qualify if:
- Participants with HIV-1 infection
- 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
You may not qualify if:
- Women of childbearing age not using effective mechanical contraception
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Unknown Facility
Aix-en-Provence, 13616, France
Unknown Facility
Angers, 49933, France
Unknown Facility
Annecy, 74011, France
Unknown Facility
Argenteuil, 95107, France
Unknown Facility
Auch, 32008, France
Unknown Facility
Aulnay-sous-Bois, 93600, France
Unknown Facility
Avignon, 84902, France
Unknown Facility
Basse-terre, 97100, France
Unknown Facility
Besançon, 25030, France
Unknown Facility
Bobigny, 93009, France
Unknown Facility
Bordeaux, 33000, France
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Boulogne, 62321, France
Unknown Facility
Bourg-en-Bresse, 01012, France
Unknown Facility
Caen, 14033, France
Unknown Facility
Carpentras, 84200, France
Unknown Facility
Cayenne, 97300, France
Unknown Facility
Cayenne, 97306, France
Unknown Facility
Colmar, 68024, France
Unknown Facility
Corbeil-Essonnes, 91106, France
Unknown Facility
Créteil, 94000, France
Unknown Facility
Fort-de-france, 97261, France
Unknown Facility
Garches, 92380, France
Unknown Facility
Kourou, 97487, France
Unknown Facility
La Roche-sur-Yon, 85025, France
Unknown Facility
Lagny-sur-Marne, 77405, France
Unknown Facility
Levallois-Perret, 92309, France
Unknown Facility
Lyon, 69317, France
Unknown Facility
Lyon, 69437, France
Unknown Facility
Mantes-la-Jolie, 78200, France
Unknown Facility
Marseille, 13006, France
Unknown Facility
Marseille, 13274, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Marseille, 13915, France
Unknown Facility
Matoury, 97351, France
Unknown Facility
Mâcon, 71000, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Nantes, 44035, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Niort, 79021, France
Unknown Facility
Nîmes, 30029, France
Unknown Facility
Orléans, 45100, France
Unknown Facility
Paris, 75010, France
Unknown Facility
Paris, 75015, France
Unknown Facility
Paris, 75018, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75674, France
Unknown Facility
Paris, 75743, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Pau, 64046, France
Unknown Facility
Perpignan, 66046, France
Unknown Facility
Pessac, 33600, France
Unknown Facility
Pointe à Pitre, 97159, France
Unknown Facility
Pontoise, 95303, France
Unknown Facility
Quimper, 29000, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Rouen, 73031, France
Unknown Facility
Saint-Denis, 93202, France
Unknown Facility
Saint-Denis, 97400, France
Unknown Facility
Saint-Dizier, 52115, France
Unknown Facility
Saint-Pierre, 97448, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Suresnes, 92150, France
Unknown Facility
Toulon, 83000, France
Unknown Facility
Toulouse, 31052, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Valenciennes, 59322, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Villejuif, 94804, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2016
First Posted
April 11, 2016
Study Start
December 1, 2004
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
April 11, 2016
Record last verified: 2016-04