Clinical trial NCT00002357: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
AIDS-Related Complex
Antiviral Agents
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 144
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Stanford
country: United States
facility: Stanford Univ School of Medicine
state: California
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
Study officials:
References: