A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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 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 load and prevent emergence of multidrug resistance.

Key facts

Study ID

NCT00000814

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

390

Expected to finish

1998-11-01

Last updated by the study team

2021-10-28

Who can join

Age: 1 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Cedars Sinai / UCLA Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Children's Hosp of Oakland — Oakland, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Univ of Connecticut / Farmington — Farmington, Connecticut, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Univ of Chicago Children's Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Univ of Maryland at Baltimore / Univ Med Ctr — Baltimore, Maryland, United States
• Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
• Univ of Alabama at Birmingham Schl of Med / Pediatrics — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.