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

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ClinicalTrials.gov Identifier: NCT00000995
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:

To evaluate the clinical and laboratory toxicity of ganciclovir (GCV) and zidovudine (AZT) when given in combination.

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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections HIV Infections Drug: Zidovudine Drug: Ganciclovir Not Applicable

Detailed Description:

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 time of developing CMV infection and requiring dose reduction of AZT for toxicity.

III: Prior therapy with GCV for CMV infection. These patients should already be in the maintenance phase, having completed a minimum of 2 weeks of induction therapy.

IV: No prior therapy with either AZT or GCV.

Treatment lasts 24 weeks and consists of two treatment plans:

A: Patients not previously treated with GCV are started on GCV for an additional 22 weeks. GCV is given as a 1-hour infusion. All patients are started on AZT at the lowest dose. B: For patients with chronic CMV disease who are receiving GCV maintenance, GCV is administered as a 1-hour infusion 5 days/week.

AZT is added and treatment with GCV is standardized prior to beginning of the study.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection
Actual Study Completion Date : February 1990

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000995


Locations
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Reichman RC
Study Chair: Richman D
Study Chair: Hochster H
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000995     History of Changes
Other Study ID Numbers: ACTG 004
10980 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Ganciclovir
Drug Evaluation
Drug Therapy, Combination
 Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Zidovudine

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Cytomegalovirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
 DNA Virus Infections
Zidovudine
Ganciclovir
Ganciclovir triphosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents