A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients (AMICI)

Roche

Status and phase: Terminated; Phase 4

Conditions: HIV Infections

Treatments: Drug: enfuvirtide [Fuzeon]; Drug: Optimized background ARV; Drug: Integrase inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00488059

ML20837

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >=18 years of age
• HIV-1 infection
• Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive
• GSS >= 3 ; nucleosides excluded

Exclusion criteria

• Adverse clinical or laboratory experience >ACTG Grade 4
• Untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen
• Malignancy requiring chemotherapy or radiotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Phase I

Experimental group

Description:

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).

Treatment:

Drug: Integrase inhibitor

Drug: Optimized background ARV

Drug: enfuvirtide [Fuzeon]

Drug: enfuvirtide [Fuzeon]

Phase II

Experimental group

Description:

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.

Treatment:

Drug: Integrase inhibitor

Drug: Optimized background ARV

Drug: enfuvirtide [Fuzeon]

Drug: enfuvirtide [Fuzeon]