A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cells/mm3. Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.

Key facts

Study ID

NCT00001029

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

654

Expected to finish

1993-05-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Required:
• PCP prophylaxis.
• Allowed:
• Erythropoietin.
• Prophylaxis for MAI or fungal infections.
• Antibiotics.
• Over-the-counter, alternative, or regularly prescribed drugs.
• Steroids, if for < 21 days.
• Concurrent Treatment:
• Allowed:
• Radiation therapy for cutaneous Kaposi's sarcoma.
• Patients must have:
• HIV infection.
• CD4 count <= 50 cells/mm3.
• Prior nucleoside monotherapy for at least 6 months.
• Life expectancy of at least 6 months.
• Prior Medication: Required:
• Nucleoside monotherapy for at least 6 months. Active alcohol or drug abuse.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Severe peripheral neuropathy.
• Psychological or emotional problems sufficient to prevent study compliance.
• Concurrent Medication:
• Excluded:
• Systemic chemotherapy for malignancy.
• Acute or induction therapy for opportunistic infection.
• Patients with the following prior conditions are excluded:
• History of acute or chronic pancreatitis.
• Grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.
• Prior Medication:
• Excluded:
• Non-study nucleosides or biologic response modifiers within 7 days prior to study entry.
• Acute therapy for opportunistic process within 14 days prior to study entry.
• Acute systemic therapy for other medical conditions within 14 days prior to study entry.

Where it is running

• USC CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Univ. of Iowa Healthcare, Div. of Infectious Diseases — Iowa City, Iowa, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• Hennepin County Med. Ctr., Div. of Infectious Diseases — Minneapolis, Minnesota, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Washington U CRS — St Louis, Missouri, United States
• Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. — Omaha, Nebraska, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States

Full record on ClinicalTrials.gov

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