- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002357
The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
A Multicenter, Randomized, Double-Blinded, Dose-Escalation Study Evaluating the Safety and Antiretroviral Activity of HBY 097 Versus HBY 097 Plus AZT in Patients With Asymptomatic or Mildly Symptomatic HIV Infection
To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone.
PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.
Study Overview
Detailed Description
Patients are randomized to receive one of three doses of HBY 097 with or without AZT or AZT alone for 12 weeks (AZT monotherapy arm eliminated per 1/19/96 amendment). All patients at a given dose level of HBY 097 must be enrolled and adequate safety data obtained before escalation in subsequent patients begins. Additional patients are entered at the optimal dose of HBY 097. Patients are evaluated weekly for the first 4 weeks and then every 2 weeks for the next 9 weeks.
PER AMENDMENT: Enrollment to the lowest dose cohort is completed.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
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Stanford, California, United States, 943055107
- Stanford Univ School of Medicine
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown Univ Med Ctr
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Georgia
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Augusta, Georgia, United States, 30912
- Med College of Georgia
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New York
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New York, New York, United States, 10016
- New York Univ Med Ctr
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Texas
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Houston, Texas, United States, 77006
- Houston Clinical Research Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Treatment for opportunistic infection that develops on study.
Recommended:
- PCP prophylaxis if CD4 count falls below 200 cells/mm3.
Patients must have:
- HIV infection.
- CD4 count 200 - 500 cells/mm3.
- HIV-1 RNA PCR value of 10000 copies/ml or higher.
- Asymptomatic or mildly symptomatic disease.
- No past or current AIDS-defining event.
- Consent of parent or guardian if less than legal age of consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Endocrine, hepatic, renal, or gastrointestinal disease.
- Cardiovascular conduction disease.
- Concomitant medical illness that may complicate study conduct or interpretation of results.
- Other factors that may interfere with patient compliance.
Concurrent Medication:
Excluded:
- Antiretroviral agents other than study drugs.
- Oral contraceptives.
- Cytotoxic chemotherapy.
- Immunomodulators.
- Antiproliferative agents.
- Corticosteroids.
- Anabolic steroids.
- Estrogens.
- Quinoxaline derivatives.
Concurrent Treatment:
Excluded:
- Radiation therapy.
Patients with the following prior conditions are excluded:
- History of hypersensitivity to quinoxaline derivatives or intolerance to AZT.
- History of cardiovascular conduction disease.
- Prior participation in this study or any study using HBY 097.
- Recent use of a drug that interferes with drug metabolism, absorption, distribution, or excretion.
- History of thyroid disease.
Prior Medication:
Excluded at any time:
Prior non-nucleoside reverse transcriptase inhibitors.
Excluded within 30 days prior to study entry:
- Any antiretroviral therapy.
- Oral contraceptives.
- Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons.
- Cytotoxic chemotherapeutic agents.
- Other investigational drugs.
Excluded within 6 months prior to study entry:
Immunotherapeutic vaccine.
Prior Treatment:
Excluded within 30 days prior to study entry:
- Radiation therapy.
- An experimental device. Current ethanol or illicit drug abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Zidovudine
Other Study ID Numbers
- 252A
- HBY097/2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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