A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.

Key facts

Study ID

NCT00000625

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2100

Expected to finish

1995-11-01

Last updated by the study team

2021-11-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• PCP prophylaxis, M. tuberculosis prophylaxis, short courses of acyclovir, chronic suppressive acyclovir, pneumovax or Hib vaccine, antibiotics, rEPO and G-CSF for grade 3 or worse anemia and neutropenia, systemic corticosteroids for < 21 days, regularly prescribed medications, and vitamins or herbal therapies.
• Patients must have:
• HIV infection without AIDS with CD4 200-500 cells/mm3.
• PER AMENDMENT 4/5/95:
• Patients must have remained on ACTG 175 study treatment through 4/30/95 and meet toxicity management criteria for continuing treatment. Subjects taking ACTG 175 crossover treatment are eligible.

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions are excluded:
• Current AIDS-related condition other than minimal KS, grade 2 or worse peripheral neuropathy, and malignancy requiring systemic therapy.
• Concurrent Medication:
• Excluded:
• Other anti-HIV drugs, biologic response modifiers other than rEPO and G-CSF, systemic cytotoxic chemotherapy, chronic systemic corticosteroids, or any drug that affects AZT glucuronidation or clearance.
• Concurrent Treatment:
• Excluded:
• Radiotherapy other than limited local therapy to skin.
• Patients with the following prior conditions are excluded:
• AIDS-related condition other than minimal KS; intolerance to AZT, ddI, or ddC at study doses; and acute or chronic pancreatitis.
• Prior Medication:
• Excluded:
• Acute therapy for an infection or other medical illness within the past 14 days.
• Current alcohol abuse.

Where it is running

• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• Stanford CRS — Palo Alto, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, 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
• Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Emory Univ. Hemophilia Program Office — Atlanta, Georgia, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG 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
• Tulane Hemophilia Treatment Ctr. — New Orleans, Louisiana, United States
• Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU — New Orleans, Louisiana, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Alabama Therapeutics CRS — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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