Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Didanosine; Efavirenz; Emtricitabine

Criteria

Inclusion Criteria:

• HIV infected

• Antiretroviral naive OR have received no more than 56 days of drugs to prevent mother-to-child transmission of HIV OR have received less than 7 total days of antiretroviral therapy

• Viral load of 5,000 copies/ml or more

• Any Center for Disease Control (CDC) classification and immune status

• Able to swallow study medications

• Parent or guardian willing to provide informed consent, if applicable

• Willing to use acceptable forms of contraception

• female subjects of childbearing potential with a negative serum beta human chronic gonadotropin

Exclusion Criteria:

• Allergic to study medications or their formulations

• Kidney disease

• Positive for hepatitis B or C

• Acute opportunistic infection (OI) or bacterial infection requiring treatment at study entry

• Taking drugs to treat tuberculosis

• Taking anti-HIV drugs other than those included in this study

• Hemoglobin >= grade 3 at screening

• Absolute Neutrophil counts >= grade 2 at screening

• Platelets >= Grade 2 at screening

• Bilirubin >= Grade 2 at screening

• SGOT (AST), SGPT(ALT) >= Grade 2 at screening

• Non-fasting triglycerides >= Grade 2 at screening. Confirmed by a 2nd determination >=100 mg/dl at fasting state

• Pancreatic amylase or total amylase+ lipase >= Grade 2 at screening

• Taking any investigational drugs

• Anti-cancer drugs within 1 year of study screening

• Serious medical event within 21 days of study screening

• Active or history of pancreatitis

• Require certain medications. Patients requiring short courses of steroids (less than 14 days) for asthma are not excluded.

• Active or history of significant peripheral neuropathy

• Difficulty with food or severe chronic diarrhea within 30 days before study entry

• Unable to eat at least 1 meal per day (or to feed at least 3 times per day, for infants) because of chronic nausea, vomiting, swallowing problems, or stomach upset

• Unable to swallow oral medications

• Pregnant or breastfeeding