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Home > "A" Clinical Trials Conditions > A Study of AZT Plus Ganciclovir in Patients with AIDS and Cytomegalovirus (CMV) Infection  A Study of AZT Plus Ganciclovir in Patients with AIDS and Cytomegalovirus (CMV) Infection
A Study of AZT Plus Ganciclovir in Patients with AIDS and Cytomegalovirus (CMV) Infection
For Condition: Cytomegalovirus Infections,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
ReichmanRC, Study Chair,
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG 004;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000995
Other Hiv Infections Studies:
1. Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
2. Transfusion Infections Pediatric Prospective Study (TRIPPS)
3. A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
4. Infection and Cardiovascular Disease
5. Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study
Related Studies:
Other HIV Infections Clinical Trials
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A Study of AZT Plus Ganciclovir in Patients with AIDS and Cytomegalovirus (CMV) Infection
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