Completed
A Phase III, Open-Label, AUC-Controlled Study to Determine the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of DMP 266 Efavirenz in Combination With Nelfinavir in Children
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
103
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Who Can Participate
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).
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