Search / Trial NCT00001057

The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

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

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Trial Information

Current as of December 26, 2024

Completed

Keywords

Didanosine Drug Therapy, Combination Zidovudine

ClinConnect Summary

Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.

Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • • Antibiotics for bacterial infections as clinically indicated.
  • • Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively.
  • • Antipyretics.
  • • Analgesics.
  • • Allergy medications.
  • • Oral contraceptives.
  • • Nonprescription medications such as vitamins or herbal therapies.
  • Concurrent Treatment:
  • Allowed:
  • • Radiation therapy to local lesion only.
  • • Acupuncture.
  • Patients must have:
  • • HIV seropositivity.
  • • CD4 count \>= 550 cells/mm3.
  • • No ARC or AIDS conditions by CDC criteria.
  • • Consent of parent or guardian if less than 18 years of age.
  • • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • • Presence of factors predisposing to pancreatitis such as active alcoholism.
  • • Other medical conditions that would interfere with study compliance.
  • Concurrent Medication:
  • Excluded:
  • • Other antiretrovirals or systemic immunomodulators.
  • • Systemic corticosteroids.
  • • Systemic cytotoxic chemotherapy.
  • • Intravenous pentamidine.
  • Concurrent Treatment:
  • Excluded:
  • • Radiation therapy except to local lesion.
  • Patients with the following prior conditions are excluded:
  • • History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month.
  • • History of grade 2 or worse peripheral neuropathy.
  • • History of pancreatitis.
  • • Bacterial infection requiring antibiotics within 14 days prior to study entry.
  • Prior Medication:
  • Excluded:
  • • Prior HIV therapy with antiretrovirals or systemic immunomodulators.
  • Prior Treatment:
  • Excluded within 2 weeks prior to study entry:
  • • Transfusion.
  • • Active substance abuse or alcoholism.

Trial Officials

Erice A

Study Chair

Balfour H

Study Chair

Carey J

Study Chair

Henry K

Study Chair

Hasse A

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

Cleveland, Ohio, United States

Omaha, Nebraska, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

Minneapolis, Minnesota, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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