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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Page 1 of 2 (7 locations)

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