Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)

Summary

To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously known as HPMPC) for the treatment of retinitis.

Conditions

• HIV Infections
• CMV Cytomegalovirus Retinitis

Interventions

DRUG

Cidofovir

Three groups: 1. the deferral group, treatment deferred until retinitis progressed 2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks. 3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• New Jersey Medical School

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Miami

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Douglas Jabs, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1994-04-30

Primary Completion

1996-02-29

Completion

1996-02-29