Status:
COMPLETED
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
6-20 years
Phase:
PHASE1
Brief Summary
To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of cl...
Detailed Description
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral loa...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Erythropoietin.
Concurrent Treatment:
Allowed:
- Transfusion.
Patients must have:
- Progressive HIV disease.
- At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Active malignancy requiring chemotherapy.
- Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.
- Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.
Concurrent Medication:
Excluded (unless exemption made by study chair):
- Oral anticoagulants (warfarin, dicumarol).
- Oral contraceptives.
- Digitalis glycosides.
- Phenytoin.
- Theophylline.
Patients with the following prior conditions are excluded:
- History of clinical pancreatitis.
- History of grade 2 or worse peripheral neuropathy.
Prior Treatment:
Excluded:
- Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 1998
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00000814
End Date
November 1 1998
Last Update
October 28 2021
Active Locations (68)
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1
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States, 35294
2
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
3
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
4
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033