BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

Roche

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: PI; Drug: Background ARVs; Drug: enfuvirtide [Fuzeon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326963

ML19712

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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142 participants in 1 patient group

Enfuvirtide+PI+ARV's

Experimental group

Description:

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).

Treatment:

Drug: Background ARVs

Drug: PI

Drug: enfuvirtide [Fuzeon]