Status:
COMPLETED
Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
6-10 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of ...
Detailed Description
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD...
Eligibility Criteria
Inclusion Criteria
Patients must:
- Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.
- Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody
- Have parent or legal guardian willing to sign a consent.
Prior Medication: Required:
- On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
- Intractable diarrhea or vomiting.
- Current clinical or laboratory Grade 3 or worse toxicities.
Concurrent Medication:
Excluded:
- Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.
- Chemotherapy for active malignancy.
Patients with any of the following prior conditions are excluded:
- Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.
- Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
- Subjects who have had chemotherapy for active malignancy.
Prior Medication:
Excluded:
- Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1998
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00000851
End Date
October 1 1998
Last Update
November 4 2021
Active Locations (35)
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1
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90502
2
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
3
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States, 06032
4
Connecticut Children's Med. Ctr.
Hartford, Connecticut, United States