Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
Hoffmann-La Roche
ClinicalTrials.gov Identifier
NCT02733419

First received: April 5, 2016
Last updated: April 5, 2016
Last Verified: April 2016
History of Changes
Purpose

Purpose

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 (

Condition Intervention Phase
HIV Infections

Drug : Enfuvirtide
Drug : Optimized background antiretroviral regimen (OB)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures

  • Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52 [ Time Frame: Week 52 ]
Secondary Outcome Measures:
  • 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 ]
  • Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score [ Time Frame: Weeks 2, 4, 8, and 24 ]
  • 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 ]
  • Change from baseline in viral load [ Time Frame: Baseline up to Week 52 or premature withdrawal ]
  • Proviral deoxyribonucleic acid (DNA) level [ Time Frame: Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal ]
  • Time to reappearance of viral load above 50 copies/mL in randomized participants [ Time Frame: 52 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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) ]
  • 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 ]
  • 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) ]

Enrollment: 84
Study Start Date: December 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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).
Drug: Enfuvirtide

Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.

Other Name: Fuzeon
Drug: 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.

Experimental: 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).
Drug: Enfuvirtide

Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.

Other Name: Fuzeon
Drug: 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.

Experimental: 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).
Drug: Enfuvirtide

Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.

Other Name: Fuzeon
Drug: 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02733419

Locations

France
Aix En Provence, France, 13616
Angers, France, 49933
Annecy, France, 74011
Argenteuil, France, 95107
Auch, France, 32008
Aulnay Sous Bois, France, 93600
Avignon, France, 84902
Basse-terre, France, 97100
Besancon, France, 25030
Bobigny, France, 93009
Bordeaux, France, 33000
Bordeaux, France, 33076
Boulogne, France, 62321
Bourg En Bresse, France, 01012
Caen, France, 14033
Carpentras, France, 84200
Cayenne, France, 97300
Cayenne, France, 97306
Colmar, France, 68024
Corbeil-essonnes, France, 91106
Creteil, France, 94000
Fort-de-france, France, 97261
Garches, France, 92380
Kourou, France, 97487
La Roche Sur Yon, France, 85025
Lagny-sur-marne, France, 77405
Levallois Perret, France, 92309
Lyon, France, 69317
Lyon, France, 69437
Macon, France, 71000
Mantes La Jolie, France, 78200
Marseille, France, 13006
Marseille, France, 13274
Marseille, France, 13385
Marseille, France, 13915
Matoury, France, 97351
Montpellier, France, 34295
Nantes, France, 44035
Nice, France, 06202
Nimes, France, 30029
Niort, France, 79021
Orleans, France, 45100
Paris, France, 75010
Paris, France, 75015
Paris, France, 75018
Paris, France, 75571
Paris, France, 75651
Paris, France, 75674
Paris, France, 75743
Paris, France, 75970
PAU, France, 64046
Perpignan, France, 66046
Pessac, France, 33600
Pointe À Pitre, France, 97159
Pontoise, France, 95303
Quimper, France, 29000
Rennes, France, 35033
Rouen, France, 73031
Saint Pierre, France, 97448
Saint-denis, France, 93202
Saint-denis, France, 97400
Saint-dizier, France, 52115
Strasbourg, France, 67091
Suresnes, France, 92150
Toulon, France, 83000
Toulouse, France, 31052
Toulouse, France, 31059
Tours, France, 37044
Valenciennes, France, 59322
Vandoeuvre-les-nancy, France, 54511
Villejuif, France, 94804

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Chair: Clinical Trials Hoffmann-La Roche
More Information

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT02733419   History of Changes  
Other Study ID Numbers: ML18242  
Study First Received: April 5, 2016  
Last Updated: April 5, 2016  

Additional relevant MeSH terms:
Infection
HIV Infections
Anti-Retroviral Agents
Enfuvirtide

ClinicalTrials.gov processed this data on August 16, 2019
This information is provided by ClinicalTrials.gov.