Expired Study
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Washington, District of Columbia 20007


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 summary:

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.


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 is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

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

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

13 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Endpoint Classification: Safety Study, Masking:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Study Dates

Verification Date:May 1997
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:HBY 097
Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoechst Marion Roussel

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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