Status:

COMPLETED

Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Cytomegalovirus Retinitis

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

NA

Brief Summary

To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS who would otherwise be treated with ganciclovir (DHPG) alone. CMV re...

Detailed Description

CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most ...

Eligibility Criteria

Inclusion Criteria

Prior Medication:

Required:

  • Patients must have successfully completed remission induction therapy with ganciclovir (minimum of 14 days of therapy) for acute cytomegalovirus (CMV) retinitis within the preceding 48 hours. Patients who show no evidence of progressive disease are considered to have met criteria for successful induction.

Amended to allow:

  • Investigational triazoles.
  • Human recombinant erythropoietin (Eprex).
  • Other investigational non-antiviral therapies offered through treatment IND.

Patients must:

  • Have HIV infection as determined by a commercially licensed ELISA test confirmed by a licensed Western blot
  • Have salvageable vision (corrected acuity of 20/100 or better) in at least one eye.
  • Be capable of signing an informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Known or suspected allergy to one of the study medications.
  • Inability to maintain adequate hydration status.

Concurrent Medication:

Excluded:

  • Concurrent therapy with nephrotoxic agents.
  • Systemic therapy for another opportunistic infection.
  • Systemic prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Probenecid.
  • Patients are advised that validity of this trial may be jeopardized by use of other potentially antiviral or immunomodulating treatments.

Patients with the following are excluded:

  • Known or suspected allergy to one of the study medications.
  • Inability to maintain adequate hydration status.

Prior Medication:

Excluded within 2 weeks of study entry:

  • Steroids.
  • Cytotoxic or immunosuppressive drugs.
  • Investigational agents. (Amended to now allow these.) Immunomodulatory drugs (except ganciclovir).

Prior Treatment:

Excluded within 2 weeks of study entry:

  • Radiotherapy.

Risk Behavior:

Excluded:

  • History of unreliable drug intake and inability to cooperate in the testing procedures. Unwilling or unable to give informed consent or unwilling to sign approved consent form.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

March 1 1992

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT00000693

End Date

March 1 1992

Last Update

November 2 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Northwestern Univ Med School

Chicago, Illinois, United States, 60611

2

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States, 60612