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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000995 |
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 | Intervention |
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Cytomegalovirus Infections HIV Infections |
Drug: Zidovudine Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | Phase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection |
Estimated Enrollment: | 60 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Excluded:
Patients with the following prior conditions are excluded if they:
Prior Medication:
Excluded within 1 week of study entry:
Prior Treatment:
Excluded within 2 weeks of study entry (for treatment group I):
All patients must be:
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 |
Study Chair: | Reichman RC | |
Study Chair: | Richman D | |
Study Chair: | Hochster H |
Study ID Numbers: | ACTG 004 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000995 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Ganciclovir Drug Evaluation Drug Therapy, Combination |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Zidovudine |
Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections |
Antimetabolites Communicable Diseases Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |