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HIV InfectionsPhase 3NCT02733419

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

A Phase 3 study testing Enfuvirtide and Optimized background antiretroviral regimen (OB) in people with HIV Infections, run by Hoffmann-La Roche at 71 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Enfuvirtide and Optimized background antiretroviral regimen (OB)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
71 sitesFrance
Study dates
Dec 2004to Mar 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

71 sites in 1 country.

71 sites in 1 country

France71 sites

  • Study site

    Aix-en-Provence, 13616

  • Study site

    Angers, 49933

  • Study site

    Annecy, 74011

  • Study site

    Argenteuil, 95107

  • Study site

    Auch, 32008

  • Study site

    Aulnay-sous-Bois, 93600

  • Study site

    Avignon, 84902

  • Study site

    Basse-terre, 97100

  • Study site

    Besançon, 25030

  • Study site

    Bobigny, 93009

  • Study site

    Bordeaux, 33000

  • Study site

    Bordeaux, 33076

  • Study site

    Boulogne, 62321

  • Study site

    Bourg-en-Bresse, 01012

  • Study site

    Caen, 14033

  • Study site

    Carpentras, 84200

  • Study site

    Cayenne, 97300

  • Study site

    Cayenne, 97306

  • Study site

    Colmar, 68024

  • Study site

    Corbeil-Essonnes, 91106

  • Study site

    Créteil, 94000

  • Study site

    Fort-de-france, 97261

  • Study site

    Garches, 92380

  • Study site

    Kourou, 97487

  • Study site

    La Roche-sur-Yon, 85025

  • Study site

    Lagny-sur-Marne, 77405

  • Study site

    Levallois-Perret, 92309

  • Study site

    Lyon, 69317

  • Study site

    Lyon, 69437

  • Study site

    Mâcon, 71000

  • Study site

    Mantes-la-Jolie, 78200

  • Study site

    Marseille, 13006

  • Study site

    Marseille, 13274

  • Study site

    Marseille, 13385

  • Study site

    Marseille, 13915

  • Study site

    Matoury, 97351

  • Study site

    Montpellier, 34295

  • Study site

    Nantes, 44035

  • Study site

    Nice, 06202

  • Study site

    Nîmes, 30029

  • Study site

    Niort, 79021

  • Study site

    Orléans, 45100

  • Study site

    Paris, 75010

  • Study site

    Paris, 75015

  • Study site

    Paris, 75018

  • Study site

    Paris, 75571

  • Study site

    Paris, 75651

  • Study site

    Paris, 75674

  • Study site

    Paris, 75743

  • Study site

    Paris, 75970

  • Study site

    Pau, 64046

  • Study site

    Perpignan, 66046

  • Study site

    Pessac, 33600

  • Study site

    Pointe à Pitre, 97159

  • Study site

    Pontoise, 95303

  • Study site

    Quimper, 29000

  • Study site

    Rennes, 35033

  • Study site

    Rouen, 73031

  • Study site

    Saint-Denis, 93202

  • Study site

    Saint-Denis, 97400

  • Study site

    Saint-Dizier, 52115

  • Study site

    Saint-Pierre, 97448

  • Study site

    Strasbourg, 67091

  • Study site

    Suresnes, 92150

  • Study site

    Toulon, 83000

  • Study site

    Toulouse, 31052

  • Study site

    Toulouse, 31059

  • Study site

    Tours, 37044

  • Study site

    Valenciennes, 59322

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Villejuif, 94804

Other trials in France

About this study

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

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).

Conditions
HIV Infections
Being tested
Enfuvirtide, Optimized background antiretroviral regimen (OB)
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnfuvirtideDrug

    Also called Fuzeon

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

  • Optimized background antiretroviral regimen (OB)Drug

    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.

Study groups in NCT02733419
Study groupRoleWhat they receive
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).
Receives: Drug: Enfuvirtide; Drug: Optimized background antiretroviral regimen (OB)
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).
Receives: Drug: Enfuvirtide; Drug: Optimized background antiretroviral regimen (OB)
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).
Receives: Drug: Enfuvirtide; Drug: Optimized background antiretroviral regimen (OB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52

    Measured: Week 52

Secondary outcomes (13)

  1. Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL)

    Measured: Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52

  2. Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score

    Measured: Weeks 2, 4, 8, and 24

  3. Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score

    Measured: Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal

  4. Change from baseline in viral load

    Measured: Baseline up to Week 52 or premature withdrawal

  5. Proviral deoxyribonucleic acid (DNA) level

    Measured: Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal

  6. Time to reappearance of viral load above 50 copies/mL in randomized participants

    Measured: 52 weeks

  7. Changes from baseline in CD4 and CD8 cell counts

    Measured: Day -35 (screening), Day 0 (inclusion), Weeks 4, 12, 24, 28, 36, 44, and 52 or premature withdrawal

  8. Number of virologic failure participants with reverse transcriptase, protease, and coating resistance mutations for plasma HIV-1 RNA and proviral DNA

    Measured: Day 0 (inclusion) up to Week 52

  9. Number of participants with cause of virologic failure

    Measured: Day 0 (inclusion), Weeks 2, 4, 8, 16, 28, 32, 36, 44, and 52 or premature withdrawal

  10. Number of participants who complied with enfuvirtide treatment, as assessed by counting treatment units returned versus supplied

    Measured: Weeks 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52

  11. Number of participants with adverse events

    Measured: 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)

  12. Number of participants with missed treatment doses or injections as assessed by compliance questionnaire

    Measured: Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal

  13. Number of participants with injection site reaction

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2016 (estimated)
  2. Study startDec 2004
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02733419
Sponsor's protocol ID
ML18242
Status last verified
Apr 2016
First submitted
5 Apr 2016
Last updated
11 Apr 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enfuvirtide and Optimized background antiretroviral regimen (OB) in people with HIV Infections, run by Hoffmann-La Roche at 71 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02733419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.

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