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Sponsored by: |
Hoechst Marion Roussel |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002357 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: HBY 097 Drug: Zidovudine |
Phase II |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Zidovudine Hby 097 |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 144 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Recommended:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded at any time:
Prior non-nucleoside reverse transcriptase inhibitors.
Excluded within 30 days prior to study entry:
Excluded within 6 months prior to study entry:
Immunotherapeutic vaccine.
Prior Treatment:
Excluded within 30 days prior to study entry:
United States, California | |||||
Los Angeles County - USC Med Ctr | |||||
Los Angeles, California, United States, 90033 | |||||
Stanford Univ School of Medicine | |||||
Stanford, California, United States, 943055107 | |||||
United States, District of Columbia | |||||
Georgetown Univ Med Ctr | |||||
Washington, District of Columbia, United States, 20007 | |||||
United States, Georgia | |||||
Med College of Georgia | |||||
Augusta, Georgia, United States, 30912 | |||||
United States, New York | |||||
New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
United States, Texas | |||||
Houston Clinical Research Network | |||||
Houston, Texas, United States, 77006 |
Hoechst Marion Roussel |
Study ID Numbers: | 252A, HBY097/2001 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002357 |
Health Authority: | United States: Food and Drug Administration |
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