A Multicenter, Open-label Study Evaluating the Safety and Efficacy of a New Protease Inhibitor (Darunavir) With Fuzeon® (Enfuvirtide) Plus Background Antiretroviral Regimen in HIV-1 Infected, Triple-class Treatment-experienced Patients
Overview
- Phase
- Phase 4
- Intervention
- Background ARVs
- Conditions
- HIV Infections
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 142
- Primary Endpoint
- Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients, \>=18 years of age;
- •seropositive for HIV-1;
- •enrolled in an early access program for a new investigational PI;
- •naive to Fuzeon, and the investigational PI;
- •treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
Exclusion Criteria
- •females who are pregnant or breast-feeding;
- •evidence of active, untreated opportunistic infection;
- •malignancy requiring chemotherapy or radiotherapy.
Arms & Interventions
Enfuvirtide+PI+ARV's
Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
Intervention: Background ARVs
Enfuvirtide+PI+ARV's
Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
Intervention: PI
Enfuvirtide+PI+ARV's
Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
Intervention: enfuvirtide [Fuzeon]
Outcomes
Primary Outcomes
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Time Frame: Week 24
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results \<50 copies/mL is reported.
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Time Frame: Week 24
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results \<50 copies/mL is reported.
Secondary Outcomes
- Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL(Week 4 and 12)
- Change From Baseline in CD4+ Lymphocyte Count(Baseline (Day 1), Weeks 4, 12, and 24)
- Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL(Weeks 4, 12, and 24)
- Percentage of Participants Meeting Virologic Failure Criteria(Weeks 12 and 24)
- Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL(Week 4 and 12)
- Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL(Weeks 4, 12, and 24)
- Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event(Week 1 to Week 24)
- Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.(Week 24)
- Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load(Baseline (Day 1), Weeks 4, 12, and 24)
- Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)(Up to Week 28)
- Percentage of Participants Adhering to ENF(Weeks 4, 12, and 24)
- Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event(Week 1 to Week 24)
- Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events(Up to Week 24)
- Number of Participants Meeting Virologic Failure Criteria(Weeks 12 and 24)
- Number of Participants Adhering to Enfuvirtide (ENF)(Weeks 4, 12, and 24)