Trials
Search / Trial NCT00000781

A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/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 Acquired Immunodeficiency Syndrome Zidovudine Nevirapine

ClinConnect Summary

The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while mi...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Required:
  • PCP prophylaxis.
  • Allowed:
  • Erythropoietin maintenance.
  • G-CSF and GM-CSF.
  • Prophylaxis for Mycobacterium avium intracellulare.
  • Antifungal prophylaxis or treatment with specific drugs.
  • Maintenance therapy for opportunistic infection.
  • Over-the-counter medications or alternative therapies such as vitamins and herbs.
  • Antibiotics as clinically indicated.
  • Steroids for \< 21 days for acute problems.
  • Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications.
  • Concurrent Treatment:
  • Allowed:
  • Radiation therapy for cutaneous Kaposi's sarcoma.
  • Acupuncture.
  • Patients must have:
  • Documented HIV infection.
  • CD4 count \<= 50 cells/mm3.
  • Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance.
  • Life expectancy of at least 6 months.
  • Consent of parent or guardian if \< 18 years of age.
  • Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment).
  • NOTE:
  • Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Abnormal baseline chest x-ray.
  • New pulmonary or cardiac symptoms.
  • Psychological or emotional problems sufficient to prevent compliance with study medication.
  • Concurrent Medication:
  • Excluded:
  • Systemic chemotherapy for malignancy.
  • Acute or induction therapy for opportunistic infection.
  • Antiretroviral drugs other than study drugs.
  • Biological response modifiers.
  • Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin.
  • Patients with the following prior conditions are excluded:
  • History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.
  • Evidence of active pulmonary disease within 6 months prior to study entry.
  • History of grade 3 or worse peripheral neuropathy.
  • History of acute or chronic pancreatitis.
  • Prior Medication:
  • Excluded:
  • Prior nevirapine.
  • Excluded within 7 days prior to study entry:
  • Acute therapy for opportunistic infection (maintenance therapy is permitted).
  • Acute systemic therapy for a nonopportunistic infection or other medical condition.
  • Antiretroviral drugs other than AZT, ddI, or ddC.
  • Biological response modifiers.
  • d4T therapy.
  • Nucleosides other than those used in the study.
  • Antibiotics containing clavulanate potassium.
  • Prior Treatment:
  • Excluded:
  • More than 4 units of blood in a 30-day period.
  • Active alcohol or drug abuse.

Trial Officials

Henry WK

Study Chair

Kahn JO

Study Chair

Balfour HH

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

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Worcester, Massachusetts, United States

Saint Louis, Missouri, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

Pasadena, California, United States

San Diego, California, United States

Washington, District Of Columbia, United States

Chicago, Illinois, United States

New Brunswick, New Jersey, 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

Cleveland, Ohio, United States

Columbus, Ohio, United States

Los Angeles, California, United States

San Francisco, California, United States

San Jose, California, United States

Stanford, California, United States

Stanford, California, United States

Sylmar, California, United States

Torrance, California, United States

New Haven, Connecticut, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Omaha, Nebraska, United States

Newark, New Jersey, United States

Albany, New York, United States

Albany, New York, United States

Albany, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Brooklyn, New York, United States

Buffalo, New York, United States

Elmhurst, New York, United States

Manhasset, New York, United States

New York, New York, United States

Syracuse, New York, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Nashville, Tennessee, United States

Galveston, Texas, United States

San Juan, , Puerto Rico

San Francisco, California, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Bronx, New York, United States

Toledo, Ohio, United States

Hershey, Pennsylvania, United States

Knoxville, Tennessee, United States

Tampa, Florida, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

Washington, District Of Columbia, United States

Houston, Texas, United States

Wauwatosa, Wisconsin, United States

Denver, Colorado, United States

Denver, Colorado, United States

Denver, Colorado, United States

Louisville, Kentucky, United States

Lebanon, New Hampshire, United States

New York, New York, United States

Hershey, Pennsylvania, United States

Green Bay, Wisconsin, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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