Phase IIIb/IV Randomized, Controlled Study Evaluating an Intensification Treatment Strategy of Adding Enfuvirtide (ENF) to an Oral Highly Active AntiRetroviral Therapy (HAART) in Treatment Experienced Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 47
- Primary Endpoint
- Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase
Study Overview
Brief Summary
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.
Detailed Description
This study consisted of two phases. In the Induction phase patients were randomized at Baseline 1 (BL1) in a 1:2 ratio to receive:
- I1: HAART or
- I2: Enfuvirtide (90 mg twice a day) + HAART.
Participants who achieved viral suppression < 50 copies/mL by week 24, confirmed by week 28 or earlier, qualified to enter the Maintenance Phase which started at Baseline 2 (BL2), four weeks after confirmation of response. The Maintenance Phase consisted of three treatment groups:
- M1: HAART continued (patients from I1)
Patients on ENF+HAART (I2) were re-randomized (at a 1:1 ratio) at BL2 to:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV-1 infected adults >=18 years of age;
- •currently on antiretroviral (ARV) therapy;
- •previously treated with 2 or 3 different antiretroviral classes;
- •HIV-1 Ribonucleic acid (RNA) >=1,000 copies/mL;
- •Cluster differentiation antigen four (CD4) lymphocyte count >=200 cells/mm^3;
- •females of childbearing potential must be willing to use a reliable form of effective barrier contraception for the duration of the study and for 30 days after the last dose of study drug.
Exclusion Criteria
- •history of prior use of enfuvirtide or T-1249;
- •women who are pregnant, breastfeeding or planning to become pregnant during the study;
- •active, untreated opportunistic infection;
- •patients on treatment interruption, or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons either than toxicity management.
Arms & Interventions
ENF + HAART
Participants received Enfuvirtide (ENF) 90 mg administered by subcutaneous injection twice a day for up to 48 weeks in addition to an oral highly active antiretroviral treatment (HAART) regimen for up to 48 weeks.
Intervention: Enfuvirtide (Drug)
ENF + HAART
Participants received Enfuvirtide (ENF) 90 mg administered by subcutaneous injection twice a day for up to 48 weeks in addition to an oral highly active antiretroviral treatment (HAART) regimen for up to 48 weeks.
Intervention: Highly active antiretroviral treatment (HAART) (Drug)
HAART
Participants received an oral highly active antiretroviral treatment (HAART) regimen, consisting of 3-5 antivirals for up to 48 weeks.
Intervention: Highly active antiretroviral treatment (HAART) (Drug)
Outcomes
Primary Outcomes
Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase
Time Frame: From Baseline 1 to Week 28
Participants whose viral load achieved suppression (HIV-1 RNA \< 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.
Secondary Outcomes
- Time to Loss of Viral Response During the Maintenance Phase(From Baseline 2 to Week 48.)
- Time to Virological Failure During the Maintenance Phase(From Baseline 2 to Week 48.)
- Number of Participants With Virological Failure During the Maintenance Phase(From Baseline 2 to Week 48.)
- Number of Participants With Adverse Events (AEs) During the Induction Phase(Start of the study treatment until the end of the Induction Phase (Week 12 to Week 32))
- Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase(Baseline 1 until Week 28.)
- Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase(From Baseline 1 to Week 28)
- Change From Baseline to Week 24 in Viral Load(Baseline and Week 24)
- Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts(Baseline and Week 24)
- Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks(Week 48)
- Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks(Week 48)
- Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts(Baseline 1 and Week 48)
- Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase(Baseline 2 to Week 48.)
- Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase(Baseline 2 to Week 48.)