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Search / Trial NCT00000625

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

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

Trial Information

Current as of January 15, 2025

Completed

Keywords

Zalcitabine Didanosine Drug Therapy, Combination Aids Related Complex Antiviral Agents Zidovudine

ClinConnect Summary

Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm.

PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • 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.
  • Exclusion Criteria
  • 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.

Trial Officials

Katzenstein D

Study Chair

Hammer S

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

Birmingham, Alabama, United States

Los Angeles, California, United States

Los Angeles, California, United States

Oakland, California, United States

Palo Alto, California, United States

San Diego, California, United States

San Diego, California, United States

San Francisco, California, United States

San Jose, California, United States

San Mateo, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Newark, New Jersey, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Greensboro, North Carolina, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

San Juan, , Puerto Rico

Mbeya, , Tanzania

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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