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

April 5, 2016 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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, 33076
      • Bordeaux, France, 33000
      • 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, 69437
      • Lyon, France, 69317
      • Macon, France, 71000
      • Mantes La Jolie, France, 78200
      • Marseille, France, 13385
      • Marseille, France, 13006
      • Marseille, France, 13274
      • Marseille, France, 13915
      • Matoury, France, 97351
      • Montpellier, France, 34295
      • Nantes, France, 44035
      • Nice, France, 06202
      • Nimes, France, 30029
      • Niort, France, 79021
      • Orleans, France, 45100
      • PAU, France, 64046
      • Paris, France, 75018
      • Paris, France, 75970
      • Paris, France, 75743
      • Paris, France, 75651
      • Paris, France, 75674
      • Paris, France, 75015
      • Paris, France, 75010
      • Paris, France, 75571
      • 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, 31059
      • Toulouse, France, 31052
      • Tours, France, 37044
      • Valenciennes, France, 59322
      • Vandoeuvre-les-nancy, France, 54511
      • Villejuif, France, 94804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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
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)
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
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML18242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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