Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Dose-Response Relationship, Drug, Drug Therapy, Combination, HIV Protease Inhibitors, Nelfinavir, Reverse Transcriptase Inhibitors, Area Under Curve, efavirenz
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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).
Sites / Locations
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- Usc La Nichd Crs
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- UCSD Maternal, Child, and Adolescent HIV CRS
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Howard Univ. Washington DC NICHD CRS
- Univ. of Florida Jacksonville NICHD CRS
- Tulane/LSU Maternal/Child CRS
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- WNE Maternal Pediatric Adolescent AIDS CRS
- Univ. of Mississippi Med. Ctr Children's Hosp.
- Bronx-Lebanon Hosp. IMPAACT CRS
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- Metropolitan Hosp. Ctr.
- Harlem Hosp. Ctr. NY NICHD CRS
- NYU Med. Ctr., Dept. of Medicine
- Nyu Ny Nichd Crs
- The Children's Hosp. of Philadelphia IMPAACT CRS
- St. Christopher's Hosp. for Children
- St. Jude/UTHSC CRS
- Texas Children's Hosp. CRS
- Seattle Children's Hospital CRS
- UW School of Medicine - CHRMC
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
- San Juan City Hosp. PR NICHD CRS