Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
HIV InfectionsAcquired Immune Deficiency Syndrome
Drug: CD4-IgG2 (PRO 542)
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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