The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of June 22, 2025
Completed
Keywords
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.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Patients applied
Trial Officials
Erice A
Study Chair
Balfour H
Study Chair
Carey J
Study Chair
Henry K
Study Chair
Hasse A
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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