The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms - Full Text View

Sponsor:	Hoechst Marion Roussel
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002357

Purpose

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Hby 097

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

144

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002357

Locations

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

Sponsors and Collaborators

Hoechst Marion Roussel

More Information

No publications provided

Study ID Numbers:	252A, HBY097/2001
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002357 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
AIDS-Related Complex
Antiviral Agents
Zidovudine

Additional relevant MeSH terms:

Antimetabolites
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 09, 2009