Status:
COMPLETED
The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients with CD4 count...
Detailed Description
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 l...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 1995
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00001057
End Date
May 1 1995
Last Update
November 1 2021
Active Locations (7)
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1
Hennepin County Med Clinic
Minneapolis, Minnesota, United States, 55415
2
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
3
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, United States, 55101
4
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130