The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
|ClinicalTrials.gov Identifier: NCT00002357|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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 or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: HBY 097 Drug: Zidovudine||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002357
|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|