A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000653
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy.

As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.

Detailed Description

As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.

Patients receive oral ddC for 48 to 177 weeks.

Study Timeline

• Study Completion: 1995-06
• 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: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (35)

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

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

Children's National Med. Ctr., ACTU; 🇺🇸 Washington, District of Columbia, United States

Univ. of Miami Ped. Perinatal HIV/AIDS CRS; 🇺🇸 Miami, Florida, United States

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases; 🇺🇸 Atlanta, Georgia, United States

Cook County Hosp.; 🇺🇸 Chicago, Illinois, United States

Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.; 🇺🇸 Chicago, Illinois, United States

Chicago Children's CRS; 🇺🇸 Chicago, Illinois, United States

Scroll for more (25 remaining)