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

Primary Purpose

Cytomegalovirus Infections, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Ganciclovir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring AIDS-Related Opportunistic Infections, Ganciclovir, Drug Evaluation, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of California / San Diego Treatment Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Univ of Rochester Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000995
Brief Title
A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection
Official Title
Phase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1990 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Ganciclovir, Drug Evaluation, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reichman RC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richman D
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hochster H
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2163228
Citation
Hochster H, Dieterich D, Bozzette S, Reichman RC, Connor JD, Liebes L, Sonke RL, Spector SA, Valentine F, Pettinelli C, et al. Toxicity of combined ganciclovir and zidovudine for cytomegalovirus disease associated with AIDS. An AIDS Clinical Trials Group Study. Ann Intern Med. 1990 Jul 15;113(2):111-7. doi: 10.7326/0003-4819-113-2-111.
Results Reference
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A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection

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