A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The study examines the safety and effectiveness of ritonavir (an anti-HIV drug), alone and in combination with other anti-HIV drugs, in HIV-positive children under 2 years of age. This study will also determine the most effective doses of ritonavir for future pediatric HIV studies. Infants infected with HIV by their mothers experience faster disease progression than adults or older children. Treatment with anti-HIV drugs administered at an early age may slow disease progression in infant populations.

Key facts

Study ID

NCT00000952

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

2004-01-01

Last updated by the study team

2021-10-29

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children may be eligible for this study if they:
• Are HIV-positive. (Infants under 3 months old presumed to be HIV-positive are eligible to participate in the single-dose phase of the study.)
• Are between the ages of 4 weeks and 2 years (consent of parent or guardian required).

You may not qualify if…

• Children will not be eligible for this study if they:
• Have an opportunistic (AIDS-related) infection within 2 months of study entry.
• Are allergic to 3TC and/or ZDV.
• Have received anti-HIV drugs for 6 to 12 weeks.
• Have any infections requiring treatment.
• Are experiencing wasting (significant weight loss).
• Have any malignancies (cancer).
• Have certain immune diseases, are being fed through a tube, or have HIV-related encephalopathy (a degenerative disease of the brain).

Where it is running

• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• NYU Med. Ctr., Dept. of Medicine — New York, New York, United States
• Nyu Ny 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
• The Children's Hosp. of Philadelphia IMPAACT CRS — Philadelphia, Pennsylvania, United States
• St. Jude/UTHSC CRS — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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