Clinical Trial Result Information

Title of Study:
Expanded access program of nelfinavir mesylate new formulation 625 mg in patients with HIV infection.

Fast Facts:

Protocol number:	ML17684
Sponsor:	Roche S.p.A.
Company division:	Pharmaceutical
Product name:	Viracept
Generic name:	nelfinavir
Phase of development:	III
Therapeutic area, approved indication:	HIV Infections
Date of report:	5/1/2006

Clinical study summary:
This was an expanded access program, supplying the 625 mg formulation of Viracept (nelfinavir) to HIV-infected subjects until the formulation was commercially available. It was a multicenter, uncontrolled, open-label study, in which all patients received 4 x 625 mg Viracept tablets daily in combination with other antiretroviral drugs. The study was intended to run for 48 weeks, or until the new formulation was brought onto the market; it was prematurely terminated when the decision was made not to make the Roche Viracept 625 mg tablet commercially available. Clinical trial results other than key safety statements have not been posted due to insufficient data.

Study center(s) :
15 centers in Italy.

Objectives:
To supply the new formulation of Viracept 625 mg to HIV-infected patients requiring Viracept.

Methodology:
Following screening, patients were instructed to take Viracept 625 mg tablets, 2 tablets twice daily with food, in combination with other antiretroviral agents. At week 4, week 12 and every subsequent 12 weeks, HIV-RNA and CD4 were evaluated, vital signs measured, gastrointestinal tolerability, QoL and adherence assessed, and laboratory evaluations made. Adverse events were monitored throughout the study.

Number of patients (planned/analyzed):
300 planned; 66 enrolled before enrolment was prematurely terminated.

Diagnosis and main criteria for inclusion:
Male and female patients ≥18 years of age, with HIV infection, naïve to nelfinavir.

Test product, dose and mode of administration or test procedure:
Viracept (nelfinavir) 1250 mg po, bid, with food.

Duration of treatment:
48 weeks or until commercial availability planned. Study was prematurely terminated.

Reference therapy, dose and mode of administration or reference procedure:
N/A

Criteria for evaluation (efficacy, safety):
Efficacy: HIV-RNA (copies/mL) and percentage CD4 at each visit. QoL, adherence.

Safety: Adverse events, laboratory assessments, gastrointestinal tolerability.

Statistical methods:
Continuous variables were summarized by descriptive statistics. Categorical variables were summarized using counts of subjects and percentages. No inferential statistical analysis was performed.

Summary (efficacy, safety, other results):
A total of 26/66 patients (39.4%) reported at least one drug-related adverse event during the study. The most common adverse events were gastrointestinal disorders. Gastrointestinal tolerability was specifically assessed at each study visit. At week 4, 59 patients reported the following symptoms: diarrhoea (n=10, 16.9%), abdominal pain (n=9, 15.3%), nausea (n=6, 10.2%), constipation (n=3, 5.1%), vomiting (n=2, 3.4%), irregular evacuation of the bowels (n=1, 1.7%). At week 12, 45 patients reported the following symptoms: diarrhoea (n=9, 20.0%), abdominal pain (n=3, 6.7%) irregular evacuation of the bowels, nausea and vomiting (n=1, 2.2%). At week 24, 30 patients reported the following symptoms: diarrhoea (n=3, 10.0%), nausea and vomiting (n=2, 6.7%), abdominal pain (n=1, 3.3%). Four patients experienced serious adverse events during the study. Two SAEs (diarrhoea in one patient, and anemia in a second), were considered probably related to treatment.

Conclusions:
No conclusions can be drawn from this study, due to its early termination. The Roche Viracept 625 mg tablet evaluated in this study is not available, and is distinct from the Pfizer tablet formulation that is available in North America.