Clinical trial NCT02733419: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL)
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52
measure: Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score
timeFrame: Weeks 2, 4, 8, and 24
measure: Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score
timeFrame: Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal
measure: Change from baseline in viral load
timeFrame: Baseline up to Week 52 or premature withdrawal
measure: Proviral deoxyribonucleic acid (DNA) level
timeFrame: Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal
measure: Time to reappearance of viral load above 50 copies/mL in randomized participants
timeFrame: 52 weeks
measure: Changes from baseline in CD4 and CD8 cell counts
timeFrame: Day -35 (screening), Day 0 (inclusion), Weeks 4, 12, 24, 28, 36, 44, and 52 or premature withdrawal
measure: Number of virologic failure participants with reverse transcriptase, protease, and coating resistance mutations for plasma HIV-1 RNA and proviral DNA
timeFrame: Day 0 (inclusion) up to Week 52
measure: Number of participants with cause of virologic failure
timeFrame: Day 0 (inclusion), Weeks 2, 4, 8, 16, 28, 32, 36, 44, and 52 or premature withdrawal
measure: Number of participants who complied with enfuvirtide treatment, as assessed by counting treatment units returned versus supplied
timeFrame: Weeks 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52
measure: Number of participants with adverse events
timeFrame: 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)
measure: Number of participants with missed treatment doses or injections as assessed by compliance questionnaire
timeFrame: Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal
measure: Number of participants with injection site reaction
timeFrame: 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)
Other outcomes:
Locations:
city: Aix En Provence
country: France
city: Angers
country: France
city: Annecy
country: France
city: Argenteuil
country: France
city: Auch
country: France
city: Aulnay Sous Bois
country: France
city: Avignon
country: France
city: Basse-terre
country: France
city: Besancon
country: France
city: Bobigny
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne
country: France
city: Bourg En Bresse
country: France
city: Caen
country: France
city: Carpentras
country: France
city: Cayenne
country: France
city: Cayenne
country: France
city: Colmar
country: France
city: Corbeil-essonnes
country: France
city: Creteil
country: France
city: Fort-de-france
country: France
city: Garches
country: France
city: Kourou
country: France
city: La Roche Sur Yon
country: France
city: Lagny-sur-marne
country: France
city: Levallois Perret
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Macon
country: France
city: Mantes La Jolie
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Matoury
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Nice
country: France
city: Nimes
country: France
city: Niort
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: PAU
country: France
city: Perpignan
country: France
city: Pessac
country: France
city: Pointe À Pitre
country: France
city: Pontoise
country: France
city: Quimper
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint Pierre
country: France
city: Saint-denis
country: France
city: Saint-denis
country: France
city: Saint-dizier
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: