A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00001032
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children.

SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria.

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

Detailed Description

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.

Study Timeline

• Study Completion: 1995-04
• 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: 2021-10-28
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (47)

Long Beach Memorial Med. Ctr., Miller Children's Hosp.; 🇺🇸 Long Beach, California, United States

Usc La Nichd Crs; 🇺🇸 Los Angeles, California, United States

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS; 🇺🇸 Los Angeles, California, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.; 🇺🇸 Oakland, California, United States

UCSD Maternal, Child, and Adolescent HIV CRS; 🇺🇸 San Diego, California, United States

San Francisco Gen. Hosp.; 🇺🇸 San Francisco, California, United States

UCSF Pediatric AIDS CRS; 🇺🇸 San Francisco, California, United States

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases; 🇺🇸 Torrance, California, United States

Univ. of Connecticut Health Ctr., Dept. of Ped.; 🇺🇸 Farmington, Connecticut, United States

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease; 🇺🇸 New Haven, Connecticut, United States

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