Search / Trial NCT00001045

Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease

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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Didanosine Drug Therapy, Combination Zidovudine Nevirapine

ClinConnect Summary

Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.

Initially, all patients receive AZT alone. After detection of a 215 mutation in plasma RNA, patients are randomized to one of three treatment arms: AZT alone, AZT plus ddI, or AZT/ddI plus nevirapine. Patients are followed every 8 weeks and receive treatment for up to 4 yea...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia.
  • Antibiotics, antifungals, and antiviral medications, as clinically indicated.
  • Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider.
  • Concurrent Treatment:
  • Allowed:
  • Limited localized radiation therapy to the skin.
  • Prior Medication: Required:
  • AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry.
  • Patients must have:
  • Asymptomatic HIV infection.
  • CD4 count 300-600 cells/mm3.
  • No plasma/serum PCR for codon 215 mutation at screening.
  • Prior AZT monotherapy.
  • NOTE:
  • All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged.
  • AS PER AMENDMENT 04/03/95:
  • DOD female patients must have a negative pregnancy test within 48 hours prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Symptomatic grade 2 or worse peripheral neuropathy.
  • Unable to swallow capsules and tablets.
  • Other medical condition that contraindicates study participation.
  • Concurrent Medication:
  • Excluded:
  • Systemic cytotoxic chemotherapy.
  • Biologic response modifiers (such as interferon, ampligen, or PEG-IL2).
  • Anti-HIV agents other than study drugs.
  • Other investigational agents.
  • Foscarnet unless clinically indicated for unresponsive herpes virus infection.
  • Chronic antacid or H-2 blocker use.
  • Rifampin or rifamycin class agents.
  • Antibiotics containing clavulanic acid.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy other than limited localized therapy to skin.
  • Patients with the following prior condition are excluded:
  • History of pancreatitis.
  • Prior Medication:
  • Excluded:
  • Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT.
  • Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening.
  • Prior Treatment:
  • Excluded:
  • Blood transfusion within the preceding 2 weeks.
  • Illicit drug or alcohol abuse.

Trial Officials

Merigan TC

Study Chair

Mayers DL

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

Indianapolis, Indiana, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Columbus, Ohio, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, 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

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Francisco, California, United States

San Jose, California, United States

Stanford, California, United States

Stanford, California, United States

Torrance, California, United States

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Omaha, Nebraska, 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

Buffalo, New York, United States

Syracuse, New York, United States

Raleigh, North Carolina, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

Boston, Massachusetts, United States

Charlotte, North Carolina, United States

Los Angeles, California, United States

Minneapolis, Minnesota, United States

Denver, Colorado, United States

Toledo, Ohio, United States

Hershey, Pennsylvania, United States

Knoxville, Tennessee, United States

Iowa City, Iowa, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

Washington, District Of Columbia, United States

Nashville, Tennessee, United States

Atlanta, Georgia, United States

Washington, District Of Columbia, United States

Bethesda, Maryland, United States

Rockville, Maryland, United States

Lackland Air Force Base, Texas, United States

San Antonio, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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