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

NCT ID: NCT00000995

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1990-02-28

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.

Conditions

Cytomegalovirus Infections; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Ganciclovir; Drug Evaluation; Drug Therapy, Combination; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Zidovudine

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Zidovudine

Intervention Type: DRUG

Ganciclovir

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reichman RC

Role: STUDY_CHAIR

Richman D

Role: STUDY_CHAIR

Hochster H

Role: STUDY_CHAIR

Locations

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

Univ of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 2163228 (View on PubMed)

Other Identifiers

10980

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 004

Identifier Type: -

Identifier Source: org_study_id