Acquired Immune Deficiency Syndrome, HIV Infections
Conditions
Keywords
Treatment Experienced
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.
Interventions
DRUGCD4-IgG2 (PRO 542)
Sponsors
Progenics Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
United States
Outcome results
None listed