NCT00055185CompletedPhase 2
Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients
Progenics Pharmaceuticals, Inc.1 site in 1 country24 target enrollmentStarted: April 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Study Sites (1)
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