A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000637
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children; to compare the virological and immunological parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.

Detailed Description

AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.

Patients are placed by random selection into one of three groups to receive either AZT alone, ddI alone, or AZT and ddI. This is a double-blind study: neither patient nor treating physician knows which group patient is in. If patients are receiving either AZT or ddI alone and they develop drug toxicity (after dose reduction), or if HIV disease progresses, the alternative single drug is offered. If patients receiving both drugs develop drug toxicity (despite dose reduction) or if HIV disease progresses, they discontinue study drug and are offered the best alternative therapy. PER AMENDMENT 6/26/95: Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted. Patients who reach crossover criteria on initial blinded ddI or AZT+ddI will be unblinded and permanently discontinued from study drugs.

Study Timeline

• Study Completion: 1996-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 819

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (80)

Univ of Alabama at Birmingham Schl of Med / Pediatrics; 🇺🇸 Birmingham, Alabama, United States

Kaiser Permanente / UCLA Med Ctr; 🇺🇸 Downey, California, United States

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

Huntington Memorial Hosp / Children's Hosp of Los Angeles; 🇺🇸 Pasadena, California, United States

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