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

Hoffmann-La Roche84 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Enfuvirtide

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (71)

Unnamed facility

Aix-en-Provence, France

Unnamed facility

Angers, France

Unnamed facility

Annecy, France

Unnamed facility

Argenteuil, France

Unnamed facility

Auch, France

Unnamed facility

Aulnay-sous-Bois, France

Outcomes

Primary Outcomes

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

Time frame: Week 52

Secondary Outcomes

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)