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Search / Trial NCT00000995

A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of May 11, 2025

Completed

Keywords

Aids Related Opportunistic Infections Ganciclovir Drug Evaluation Drug Therapy, Combination Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Zidovudine

ClinConnect Summary

Because recent information has shown AZT to be useful in treating AIDS, it is assumed that most patients with AIDS, and probably with AIDS related complex (ARC), will be receiving AZT. Because AZT is reported not to be active against cytomegalovirus (CMV), it is important to see if it is useful to give GCV along with AZT.

Patients are placed into one of four groups at entry into study according to their previous treatment:

I: Prior treatment with AZT up to the time of developing CMV infection and not requiring dose reduction of AZT for toxicity.

II: Prior treatment with AZT up to the tim...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • * Symptomatic therapy such as analgesics, antihistamines, antiemetics, and antidiarrheal agents, or other supportive therapy may be administered as deemed necessary by the responsible investigator. For fever, the following regimens should be used:
  • If fever above 39.0 degrees C, antipyretic therapy will be administered employing aspirin, 650 mg orally every 4 hours x 3 doses, or until fever falls below 39.0 degrees C.
  • If fever of higher than 39.0 degrees C occurs for 2 consecutive days, the patient may be premedicated with aspirin.
  • Exclusion Criteria
  • Active alcohol or drug abuse.
  • Co-existing Condition:
  • Excluded:
  • Patients with other life-threatening and uncontrolled opportunistic infections on enrollment.
  • Patients with the following prior conditions are excluded if they:
  • Have other life-threatening and uncontrolled opportunistic infections on enrollment.
  • Prior Medication:
  • Excluded within 1 week of study entry:
  • Systemic therapy with antimetabolite.
  • Cytotoxic drug.
  • Interferon.
  • Immunologic modulators.
  • Corticosteroids.
  • Nucleoside analogs other than zidovudine (AZT).
  • * Excluded within 2 weeks of study entry:
  • Therapy for any other opportunistic infections.
  • * Excluded within 2 months of study entry:
  • Ribavirin.
  • Prior Treatment:
  • Excluded within 2 weeks of study entry (for treatment group I):
  • Blood transfusion.
  • * Excluded within 1 month of study entry (for treatment groups II and III):
  • Blood transfusion.
  • All patients must be:
  • Able to provide informed consent.
  • Likely to be available for follow-up for at least 4 months.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

San Diego, California, United States

New York, New York, United States

Rochester, New York, United States

Patients applied

0 patients applied

Trial Officials

Reichman RC

Study Chair

Richman D

Study Chair

Hochster H

Study Chair

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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