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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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