Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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 either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden. 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 CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.

Key facts

Study ID

NCT00000851

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

198

Expected to finish

1998-10-01

Last updated by the study team

2021-11-04

Who can join

Age: 1 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Univ. of Connecticut Health Ctr., Dept. of Ped. — Farmington, Connecticut, United States
• Connecticut Children's Med. Ctr. — Hartford, Connecticut, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Cook County Hosp. — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
• UMDNJ - Robert Wood Johnson — New Brunswick, New Jersey, United States
• NJ Med. School CRS — Newark, New Jersey, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States
• North Shore-Long Island Jewish Health System, Dept. of Peds. — Great Neck, New York, United States
• Schneider Children's Hosp., Div. of Infectious Diseases — New Hyde Park, New York, United States
• Metropolitan Hosp. NICHD CRS — New York, New York, United States
• Columbia IMPAACT CRS — New York, New York, United States
• Incarnation Children's Ctr. — New York, New York, United States
• Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
• Strong Memorial Hospital Rochester NY NICHD CRS — Rochester, New York, United States

Full record on ClinicalTrials.gov

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