Back to resultsEfficacy, 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
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Enfuvirtide
Optimized background antiretroviral regimen (OB)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Enfuvirtide + OB (Not Randomized)
Enfuvirtide + OB (Randomized)
OB alone (Randomized)
Arm Description
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).
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).
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).
Outcomes
Primary Outcome Measures
Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52
Secondary Outcome Measures
Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL)
Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score
Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score
Change from baseline in viral load
Proviral deoxyribonucleic acid (DNA) level
Time to reappearance of viral load above 50 copies/mL in randomized participants
Changes from baseline in CD4 and CD8 cell counts
Number of virologic failure participants with reverse transcriptase, protease, and coating resistance mutations for plasma HIV-1 RNA and proviral DNA
Number of participants with cause of virologic failure
Number of participants who complied with enfuvirtide treatment, as assessed by counting treatment units returned versus supplied
Number of participants with adverse events
Number of participants with missed treatment doses or injections as assessed by compliance questionnaire
Number of participants with injection site reaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02733419
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enfuvirtide + OB (Not Randomized)
Arm Type
Experimental
Arm Description
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).
Arm Title
Enfuvirtide + OB (Randomized)
Arm Type
Experimental
Arm Description
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).
Arm Title
OB alone (Randomized)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Enfuvirtide
Other Intervention Name(s)
Fuzeon
Intervention Description
Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
Intervention Type
Drug
Intervention Name(s)
Optimized background antiretroviral regimen (OB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL)
Time Frame
Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52
Title
Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score
Time Frame
Weeks 2, 4, 8, and 24
Title
Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score
Time Frame
Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal
Title
Change from baseline in viral load
Time Frame
Baseline up to Week 52 or premature withdrawal
Title
Proviral deoxyribonucleic acid (DNA) level
Time Frame
Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal
Title
Time to reappearance of viral load above 50 copies/mL in randomized participants
Time Frame
52 weeks
Title
Changes from baseline in CD4 and CD8 cell counts
Time Frame
Day -35 (screening), Day 0 (inclusion), Weeks 4, 12, 24, 28, 36, 44, and 52 or premature withdrawal
Title
Number of virologic failure participants with reverse transcriptase, protease, and coating resistance mutations for plasma HIV-1 RNA and proviral DNA
Time Frame
Day 0 (inclusion) up to Week 52
Title
Number of participants with cause of virologic failure
Time Frame
Day 0 (inclusion), Weeks 2, 4, 8, 16, 28, 32, 36, 44, and 52 or premature withdrawal
Title
Number of participants who complied with enfuvirtide treatment, as assessed by counting treatment units returned versus supplied
Time Frame
Weeks 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52
Title
Number of participants with adverse events
Time Frame
Day 0 (inclusion), Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52 or premature withdrawal and follow-up (approximately up to 452 days)
Title
Number of participants with missed treatment doses or injections as assessed by compliance questionnaire
Time Frame
Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal
Title
Number of participants with injection site reaction
Time Frame
Day 0 (inclusion), Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52 or premature withdrawal and follow-up (approximately up to 452 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Aix En Provence
ZIP/Postal Code
13616
Country
France
City
Angers
ZIP/Postal Code
49933
Country
France
City
Annecy
ZIP/Postal Code
74011
Country
France
City
Argenteuil
ZIP/Postal Code
95107
Country
France
City
Auch
ZIP/Postal Code
32008
Country
France
City
Aulnay Sous Bois
ZIP/Postal Code
93600
Country
France
City
Avignon
ZIP/Postal Code
84902
Country
France
City
Basse-terre
ZIP/Postal Code
97100
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Bobigny
ZIP/Postal Code
93009
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Boulogne
ZIP/Postal Code
62321
Country
France
City
Bourg En Bresse
ZIP/Postal Code
01012
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Carpentras
ZIP/Postal Code
84200
Country
France
City
Cayenne
ZIP/Postal Code
97300
Country
France
City
Cayenne
ZIP/Postal Code
97306
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Corbeil-essonnes
ZIP/Postal Code
91106
Country
France
City
Creteil
ZIP/Postal Code
94000
Country
France
City
Fort-de-france
ZIP/Postal Code
97261
Country
France
City
Garches
ZIP/Postal Code
92380
Country
France
City
Kourou
ZIP/Postal Code
97487
Country
France
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
City
Lagny-sur-marne
ZIP/Postal Code
77405
Country
France
City
Levallois Perret
ZIP/Postal Code
92309
Country
France
City
Lyon
ZIP/Postal Code
69317
Country
France
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Macon
ZIP/Postal Code
71000
Country
France
City
Mantes La Jolie
ZIP/Postal Code
78200
Country
France
City
Marseille
ZIP/Postal Code
13006
Country
France
City
Marseille
ZIP/Postal Code
13274
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Marseille
ZIP/Postal Code
13915
Country
France
City
Matoury
ZIP/Postal Code
97351
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nantes
ZIP/Postal Code
44035
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Nimes
ZIP/Postal Code
30029
Country
France
City
Niort
ZIP/Postal Code
79021
Country
France
City
Orleans
ZIP/Postal Code
45100
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Paris
ZIP/Postal Code
75015
Country
France
City
Paris
ZIP/Postal Code
75018
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Paris
ZIP/Postal Code
75743
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
PAU
ZIP/Postal Code
64046
Country
France
City
Perpignan
ZIP/Postal Code
66046
Country
France
City
Pessac
ZIP/Postal Code
33600
Country
France
City
Pointe À Pitre
ZIP/Postal Code
97159
Country
France
City
Pontoise
ZIP/Postal Code
95303
Country
France
City
Quimper
ZIP/Postal Code
29000
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Rouen
ZIP/Postal Code
73031
Country
France
City
Saint Pierre
ZIP/Postal Code
97448
Country
France
City
Saint-denis
ZIP/Postal Code
93202
Country
France
City
Saint-denis
ZIP/Postal Code
97400
Country
France
City
Saint-dizier
ZIP/Postal Code
52115
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Suresnes
ZIP/Postal Code
92150
Country
France
City
Toulon
ZIP/Postal Code
83000
Country
France
City
Toulouse
ZIP/Postal Code
31052
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Valenciennes
ZIP/Postal Code
59322
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Villejuif
ZIP/Postal Code
94804
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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