A Phase 4 interventional study of enfuvirtide [Fuzeon] and Optimized background ARV in HIV Infections, sponsored by Hoffmann-La Roche. Terminated at 43 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-22.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 29 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
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Exclusion Criteria:
Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® \[raltegravir\] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
Drug: enfuvirtide [Fuzeon] · Drug: Optimized background ARV · Drug: Integrase inhibitor
In the randomized comparator Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL from Phase I were randomized to 1 of 2 treatment arms of (Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs or (Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
Drug: Optimized background ARV · Drug: Integrase inhibitor · Drug: enfuvirtide [Fuzeon]
90 mg SC twice daily
As prescribed
As prescribed
180 mg SC once daily
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
Virologic responders were defined as patients who had an initial HIV-1 RNA assessment \<= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)
Time frame: Between Week I-4 and Week I-12 of Phase I of the study
Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16
Time frame: Week II-16
Virologic Response Over Time in Phase I of the Study
The number of intent-to-treat (ITT) participants with HIV-1 RNA \<= 50 copies/mL and HIV-1 RNA \< 400 copies/mL by study week are summarized below.
Time frame: Weeks 4, 8 & 12
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 \& LOCF for ITT patients in Phase I of the study
Time frame: Baseline and Weeks 4, 8, 12 & LOCF
Virologic Response Over Time in Phase II of the Study
The number of intent-to-treat (ITT) participants with HIV-1 RNA \<= 50 copies/mL and HIV-1 RNA \< 400 copies/mL by study week.
Time frame: Weeks II-4, 8, 12 & 16
CD4+ Lymphocyte Count Change From Baseline
Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm. Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II - 12 and 16.
Time frame: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Time frame: Phase I and II
| Milestone | Phase I | Phase II - Arm A | Phase II - Arm B |
|---|---|---|---|
| Started | 29 | 0 | 0 |
| Completed | 14 | 0 | 0 |
| Not completed | 15 | 0 | 0 |
| Milestone | Phase I | Phase II - Arm A | Phase II - Arm B |
|---|---|---|---|
| Started | 0 | 9 | 0 |
| Completed | 0 | 7 | 0 |
| Not completed | 0 | 2 | 0 |
| Milestone | Phase I | Phase II - Arm A | Phase II - Arm B |
|---|---|---|---|
| Started | 0 | 0 | 5 |
| Completed | 0 | 0 | 1 |
| Not completed | 0 | 0 | 4 |
Virologic responders were defined as patients who had an initial HIV-1 RNA assessment \<= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)
| participants | Phase I: ENF 90mg SC BID |
|---|---|
| Week 8 | 8 |
| Week 12 | 5 |
| Week 16 | 1 |
The number of intent-to-treat (ITT) participants with HIV-1 RNA \<= 50 copies/mL and HIV-1 RNA \< 400 copies/mL by study week are summarized below.
| participants | Phase I: ENF 90mg SC BID |
|---|---|
| Week 4 (<= 50 copies/mL) | 11 |
| Week 4 (< 400 copies/mL) | 22 |
| Week 8 (<= 50 copies/mL) | 14 |
| Week 8 (< 400 copies/mL) | 22 |
| Week 12 (<= 50 copies/mL) | 14 |
| Week 12 (< 400 copies/mL) | 19 |
| participants | Phase II Arm A: Phase I Then ENF 90 mg SC BID | Phase II Arm B: Phase I Then ENF 180mg SC QD |
|---|---|---|
| Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16 | 5 | 3 |
Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 \& LOCF for ITT patients in Phase I of the study
| log10 copies/mL | Phase I: ENF 90mg SC BID |
|---|---|
| Baseline (N=29) | 4.4 ± 0.87 |
| change at Week 4 (n=27) | 2.1 ± 0.46 |
| change at Week 8 (n=24) | 2.0 ± 0.81 |
| change at Week 12 (n=14) | 2.4 ± 1.09 |
| change at Week 16 (n=10) | 2.3 ± 0.90 |
| change at LOCF (n=27) | 1.9 ± 0.61 |
The number of intent-to-treat (ITT) participants with HIV-1 RNA \<= 50 copies/mL and HIV-1 RNA \< 400 copies/mL by study week.
| participants | Phase II Arm A: Phase I Then ENF 90mg SC BID | Phase II Arm B: Phase I Then ENF 180mg SC QD |
|---|---|---|
| Week 4 (<= 50 copies/mL) | 5 | 4 |
| Week 4 (< 400 copies/mL) | 6 | 4 |
| Week 8 (<= 50 copies/mL) | 6 | 4 |
| Week 8 (< 400 copies/mL) | 7 | 4 |
| Week 12 (<= 50 copies/mL) | 6 | 4 |
| Week 12 (< 400 copies/mL) | 7 | 4 |
| Week 16 (<= 50 copies/mL) | 5 | 3 |
| Week 16 (< 400 copies/mL) | 6 | 4 |
Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm. Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II - 12 and 16.
| cells/mm3 | Phase II Arm A: Phase I Then ENF 90mg BID | Phase II Arm B: Phase I Then ENF 180mg QD |
|---|---|---|
| Phase I baseline to Week 1 of Phase II (n=8,5) | 22 (-39.0 to 139.0) | 118.0 (26.0 to 239.0) |
| Phase I baseline to Week 12 of Phase II (n=7,4) | 83.0 (3.0 to 199.0) | 174.5 (-14.0 to 301.0) |
| Phase I baseline to Week 16 of Phase II (n=6,4) | 61.0 (0.0 to 104.0) | 179.0 (18.0 to 225.0) |
| Percentage of patients | Phase I: ENF 90mg SC BID | Phase II - Arm A | Phase II - Arm B |
|---|---|---|---|
| Any type | 92 | 100 | 100 |
| Pain/discomfort | 52 | 42.9 | 60 |
| Erythema | 80 | 71.4 | 100 |
| Induration | 80 | 100 | 100 |
| Pruritus | 44 | 28.6 | 20 |
| Nodules | 56 | 57.1 | 80 |
| Ecchymosis | 40 | 14.3 | 20 |
Collected over Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I: ENF 90mg SC BID | — | 4/29 (13.8%) | 2/29 (6.9%) |
| Phase II Arm A: Phase I Then ENF 90mg SC BID | — | 0/9 (0%) | 0/9 (0%) |
| Phase II Arm B: Phase I Then ENF 180mg SC QD | — | 0/5 (0%) | 0/5 (0%) |
| Event | Phase I: ENF 90mg SC BID | Phase II Arm A: Phase I Then ENF 90mg SC BID | Phase II Arm B: Phase I Then ENF 180mg SC QD |
|---|---|---|---|
| Cerebrovascular accidentNervous system disorders | 1/29 | 0/9 | 0/5 |
| Transient ischaemic attackNervous system disorders | 1/29 | 0/9 | 0/5 |
| AnemiaBlood and lymphatic system disorders | 1/29 | 0/9 | 0/5 |
| DeathGeneral disorders | 1/29 | 0/9 | 0/5 |
| Cytomegalovirus viraemiaInfections and infestations | 1/29 | 0/9 | 0/5 |
| Suicidal ideationPsychiatric disorders | 1/29 | 0/9 | 0/5 |
| Renal failureRenal and urinary disorders | 1/29 | 0/9 | 0/5 |
| Pulmonary massRespiratory, thoracic and mediastinal disorders | 1/29 | 0/9 | 0/5 |
| Event | Phase I: ENF 90mg SC BID | Phase II Arm A: Phase I Then ENF 90mg SC BID | Phase II Arm B: Phase I Then ENF 180mg SC QD |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/29 | 0/9 | 0/5 |
| Rash morbilliformSkin and subcutaneous tissue disorders | 1/29 | 0/9 | 0/5 |
| Age Continuous(years) | Phase 1: ENF 90mg SC BID |
|---|---|
| Mean | 45.4 ± 10.30 |
| Sex: Female, Male(Participants) | Phase 1: ENF 90mg SC BID |
|---|---|
| Female | 5 |
| Male | 24 |
This study is terminated, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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