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CompletedNCT00055185Updated Oct 3, 2008

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

A Phase 2 interventional study of CD4-IgG2 (PRO 542) in HIV Infections and Acquired Immune Deficiency Syndrome, sponsored by Progenics Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-03.

Sponsored by Progenics Pharmaceuticals, Inc. (part of Lantheus Holdings, Inc.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections
  • Acquired Immune Deficiency Syndrome

Keywords

  • Treatment Experienced
03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 24 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Progenics Pharmaceuticals, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.

First submitted before Progenics Pharmaceuticals, Inc. became part of Lantheus Holdings, Inc..

Browse Progenics Pharmaceuticals, Inc. studies →All Lantheus Holdings, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants

Interventions

  • DrugCD4-IgG2 (PRO 542)
06

Study locations

1 site
  • Beth Israel Medical Center
    New York, New York 10003, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2003 and a completion of Jun 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2003
First posted
Feb 21, 2003
Start
Apr 2003
CompletionActual
Jun 2005
Last update
Oct 3, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00055185
Lead sponsor
Progenics Pharmaceuticals, Inc.
First posted
Feb 21, 2003
Start date
Apr 2003
Completion
Jun 2005
Last update
Oct 3, 2008

Study contacts

Jeffery M Jocbson, MD
principal investigator · Beth Israel Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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