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
2 other identifiers
interventional
144
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 1997
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Stanford Univ School of Medicine
Stanford, California, 943055107, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
New York Univ Med Ctr
New York, New York, 10016, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1997-05