Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)

Summary

To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir.

To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.

Conditions

• HIV Infections
• Acquired Immunodeficiency Syndrome
• Cytomegalovirus Retinitis

Interventions

DRUG

Ganciclovir

intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day

DRUG

Foscarnet

intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Johns Hopkins University

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Tulane University School of Medicine

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• New York Presbyterian Hospital

  collaborator OTHER

• New York University

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Miami

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1992-12-31

Primary Completion

1995-03-31

Completion

1995-03-31