Status:

COMPLETED

A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Bristol-Myers Squibb

Glaxo Wellcome

Conditions:

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE2

Brief Summary

To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating mo...

Detailed Description

Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in ...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Required:

  • PCP prophylaxis.

Allowed:

  • Erythropoietin.
  • Prophylaxis for MAI or fungal infections.
  • Antibiotics.
  • Over-the-counter, alternative, or regularly prescribed drugs.
  • Steroids, if for < 21 days.

Concurrent Treatment:

Allowed:

  • Radiation therapy for cutaneous Kaposi's sarcoma.

Patients must have:

  • HIV infection.
  • CD4 count <= 50 cells/mm3.
  • Prior nucleoside monotherapy for at least 6 months.
  • Life expectancy of at least 6 months.

Prior Medication: Required:

  • Nucleoside monotherapy for at least 6 months. Active alcohol or drug abuse.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Severe peripheral neuropathy.
  • Psychological or emotional problems sufficient to prevent study compliance.

Concurrent Medication:

Excluded:

  • Systemic chemotherapy for malignancy.
  • Acute or induction therapy for opportunistic infection.

Patients with the following prior conditions are excluded:

  • History of acute or chronic pancreatitis.
  • Grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.

Prior Medication:

Excluded:

  • Non-study nucleosides or biologic response modifiers within 7 days prior to study entry.
  • Acute therapy for opportunistic process within 14 days prior to study entry.
  • Acute systemic therapy for other medical conditions within 14 days prior to study entry.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

May 1 1993

Estimated Enrollment :

654 Patients enrolled

Trial Details

Trial ID

NCT00001029

End Date

May 1 1993

Last Update

November 4 2021

Active Locations (37)

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Page 1 of 10 (37 locations)

1

USC CRS

Los Angeles, California, United States, 90033

2

Stanford CRS

Palo Alto, California, United States, 94115

3

Ucsd, Avrc Crs

San Diego, California, United States, 92103

4

Ucsf Aids Crs

San Francisco, California, United States

A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past | DecenTrialz