Completed

Phase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+26

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePhase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection
NCT00000995
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeAmino Acid Metabolism, Inborn ErrorsCommunicable DiseasesCytomegalovirus InfectionsDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsAIDS-Related Opportunistic InfectionsMitochondrial DiseasesGenetic Diseases, InbornMultiple Acyl Coenzyme A Dehydrogenase Deficiency

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Univ of California / San Diego Treatment Ctr

San Diego, United StatesOpen Univ of California / San Diego Treatment Ctr in Google Maps
Suspended

Bellevue Hosp / New York Univ Med Ctr

New York, United States
Suspended

Univ of Rochester Medical Center

Rochester, United States
Completed3 Study Centers