A Study to Compare Two Different Anti-HIV Drug Regimens

Completed · Phase 2

Conditions studied: HIV Infections

In brief

This study compares 2 different anti-HIV drug regimens to determine which is the most effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor (nevirapine). These drug combinations have been previously studied in adults, but there is limited information on how well they work in HIV-infected children. It is important to develop drug combinations which are effective at suppressing the HIV virus in children.

Key facts

Study ID

NCT00000924

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

120

Expected to finish

2001-06-01

Last updated by the study team

2021-10-29

Who can join

Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are between 4 months and 21 years of age (consent of parent or guardian required if under 18).
• Are HIV-positive.
• Have a viral level of at least 4,000 copies/ml.
• Have a CD4 cell count of at least 750 (under 12 months of age), at least 500 (1 to 5 years of age), or at least 200 (6 years of age or older) cells/mm3 within the past 4 months or a CD4 percent of 15 percent or higher within the past 4 months.
• Have received the same continuous antiretroviral therapy for the past 16 weeks.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have an active opportunistic and/or serious bacterial infection.
• Have been diagnosed with a malignancy.
• Have received prior treatment with certain antiretroviral medications.
• Are pregnant or breast-feeding.

Where it is running

• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States
• Univ of South Alabama — Mobile, Alabama, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Los Angeles County - USC Med Ctr — 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
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• Univ of Florida Gainesville — Gainesville, 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
• 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
• Earl K Long Early Intervention Clinic — 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
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Massachusetts Med School — Worcester, Massachusetts, United States
• Children's Hosp of Michigan — Detroit, Michigan, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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