Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients

Progenics Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Acquired Immune Deficiency Syndrome

HIV Infections

Treatments

Drug: CD4-IgG2 (PRO 542)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00055185

TT2001

5R44AI048278-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine any adverse effects of PRO 542 after administration and to determine the anti-HIV effects of PRO 542 in the patient.

Full description

A 2 arm study involving a series of 3 triweekly doses of PRO 542. One arm will involve patients on a stable dose of anti-retroviral therapy and the other arm will consist of patients not receiving anti-retroviral therapy. Three patients will be enrolled in each arm followed by a safety evaluation. Following the safety evaluation, 3 more patients may be enrolled in each arm. After the first 12 patients, an additional 12 patients may be enrolled pending safety data.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed diagnosis of HIV
Patients must be on a stable dose of acceptable anti-HIV therapy or receiving no anti-HIV therapy for at least four (4) weeks prior to the start of this study
HIV-1 determination by RNA-PCR greater than or equal to 100,000 copies/ml
CD4 count >50/cubic mm at screening

Exclusion criteria

Patients who have previously received PRO 542
Patients with active, significant infection (other than HIV) not controlled by antibiotics
Pregnant or lactating women
Patients with an estimated life expectancy of <3 months
Patients currently receiving steroids or other immunosuppressive therapy or immunoglobulin therapy except for topical or inhaled steroids
Patients with known allergy or hypersensitivity to PRO 542 or immunoglobulin preparations