Search / Trial NCT00000718

A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 26, 2024

Completed

Keywords

Zalcitabine Dose Response Relationship, Drug Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

ClinConnect Summary

AZT extends the survival of some patients with AIDS, and both AZT and ddC are known to inhibit the growth of HIV. When AZT or ddC is given continuously over a prolonged period of time, toxic effects occur that are not found when the drugs are given for 4 - 6 weeks. It is hoped that by alternating the drugs or by giving one drug intermittently, the toxic effects can be decreased without lowering the therapeutic effectiveness of the drugs.

Patients will be assigned to 1 of 7 treatment groups. Both AZT and ddC will be given by mouth every 4 hours. One group will take AZT continuously for 52 w...

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Concurrent Medication:
  • Encouraged though not required:
  • • Inhaled pentamidine as prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • * Allowed:
  • • AL-721 use is discouraged but not prohibited.
  • • Use of aspirin, acetaminophen, and nonsteroidal anti-inflammatory agents should be minimized, with continuous use for \> 72 hours discouraged.
  • • Acute therapy (7 days) with oral acyclovir.
  • • Acute therapy with ketoconazole.
  • Concurrent Treatment:
  • Allowed:
  • • Up to 4 units of packed red blood cells for hemoglobin toxicity.
  • All patients must have the following:
  • • A consistently positive serum HIV p24 antigen = or \> 70 pg/ml, defined by the Abbott HIV antigen test, on two occasions. The tests must be within 1 month of study entry, separated by at least 72 hours, and the last must be within 2 weeks of starting therapy. Any negative antigen test during the period will exclude the patient from the study.
  • • A positive antibody to HIV confirmed by any federally licensed ELISA test kit.
  • * Patients in group A must have AIDS related complex (ARC) as defined by the documented presence of at least one of the following:
  • • Recurrent oral candidiasis.
  • • Hairy leukoplakia.
  • • History of herpes zoster.
  • • Temperature \> 38.5 degrees C with or without night sweats, persisting for \> 14 consecutive days or \> 15 days in a 30-day interval prior to study entry.
  • • Weight loss of \> 15 lbs. or 10 percent of body weight noted in a 120-day period prior to study entry.
  • • Diarrhea defined as = or \> 3 liquid stools per day, persisting for \> 30 days prior to study entry without definable cause.
  • • Patients in group B must have CDC-defined AIDS not requiring systemic maintenance chemotherapy.
  • • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • • Transfusion dependence requiring 2 units of blood more than once per month.
  • • Significant malabsorption (\> 10 percent weight loss within the past 3 months with serum carotene \< 75 IU/ml or vitamin A \< 74 IU/ml).
  • • Significant cardiac or liver disease.
  • * Significant neurologic abnormalities defined by any one of the following:
  • • A significant abnormality on the ddC Neuropathy Targeted Symptom Questionnaire defined as a symptom score \> 4 (moderate severity) in any one of six categories or a score \> 2 (mild severity) in any two of six categories.
  • • Moderate abnormalities on standardized neurologic exam.
  • • Any severe abnormality (a value = or \> 4.0) on standardized 4-arm quantitative sensory testing of vibration threshold.
  • • Diabetes, renal failure, or alcoholism.
  • • Dose-limiting or transfusion-requiring toxicity during a previous course of zidovudine therapy.
  • • History of idiopathic thrombocytopenic purpura.
  • * Requirement for prolonged acyclovir therapy. Patients in group A must not have the following:
  • • Opportunistic infection or malignancy fulfilling the CDC definition of AIDS.
  • * Neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Patients in group B must not have the following:
  • • Active opportunistic infection or AIDS-defining opportunistic infection requiring ongoing systemic therapy and/or prophylaxis other than inhaled pentamidine for Pneumocystis carinii pneumonia prophylaxis.
  • • Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry.
  • • Concurrent neoplasms other than KS, basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Concurrent Medication:
  • Excluded:
  • • Neurotoxic drugs.
  • • Prolonged acyclovir therapy.
  • • Antineoplastic therapy.
  • • Systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection, other than inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • • Other antiretroviral agents, immunomodulators, or systemic corticosteroids.
  • • Other experimental medication.
  • Concurrent Treatment:
  • Excluded:
  • • Transfusion dependency (requiring 2 units of blood more than once per month).
  • Prior Medication:
  • Excluded:
  • • Antiretroviral agents within 60 days of study entry.
  • • Biologic modifiers or corticosteroids within 30 days prior to study entry.
  • • Dideoxycytidine (ddC).
  • Prior Treatment:
  • Excluded:
  • • Blood transfusion within 2 weeks of entry.
  • • Any negative HIV p24 antigen test during the month prior to entry will exclude the patient from the study.
  • • Active drug or alcohol abuse.

Trial Officials

G Skowron

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Chicago, Illinois, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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