Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children

Completed · Phase 1

Conditions studied: HIV Infections

In brief

Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels of EFZ and NFV in the blood. (This purpose reflects a change from the original since there are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily can be combined with other drugs to treat HIV. This is an early study to determine a safe and effective dose for HIV-positive children. This study also will examine the correct dose of NFV to use in combination with EFZ.

Key facts

Study ID

NCT00000893

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

103

Starts

1997-10-01

Expected to finish

2002-12-01

Last updated by the study team

2021-10-29

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children may be eligible for this study if they:
• Are HIV-positive.
• Are between 3 months and 16 years old (consent of parent or legal guardian required). (These age requirements reflect a change.)
• Have a plasma viral load of at least 400 copies/ml at screening.
• Agree to practice abstinence or use effective methods of birth control during the study.
• Are able to take oral medication and comply with study requirements.
• Are taking at least 1 nucleoside reverse transcriptase inhibitor (NRTI), such as zidovudine (ZDV) or stavudine (d4T). Patients can begin taking NRTIs at the beginning of the study.

You may not qualify if…

• Children will not be eligible for this study if they:
• Have had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to study entry.
• Are allergic to EFZ or NFV.
• Have any disease, including hepatitis, cancer, or an active opportunistic (HIV-associated) infection.
• Are pregnant or breast-feeding.
• Are taking any other experimental drugs or certain medications.
• Have ever taken protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).

Where it is running

• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• Usc La Nichd 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
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Univ. of Mississippi Med. Ctr Children's Hosp. — Jackson, Mississippi, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States
• Metropolitan Hosp. Ctr. — New York, New York, United States
• Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
• NYU Med. Ctr., Dept. of Medicine — New York, New York, United States
• Nyu Ny Nichd Crs — New York, New York, United States
• Bronx-Lebanon Hosp. IMPAACT CRS — The Bronx, New York, United States
• The Children's Hosp. of Philadelphia IMPAACT CRS — Philadelphia, Pennsylvania, United States
• St. Christopher's Hosp. for Children — Philadelphia, Pennsylvania, United States
• St. Jude/UTHSC CRS — Memphis, Tennessee, United States
• Texas Children's Hosp. CRS — Houston, Texas, United States
• Seattle Children's Hospital CRS — Seattle, Washington, United States
• UW School of Medicine - CHRMC — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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