Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Didanosine; Efavirenz; Lamivudine; Lopinavir; Nevirapine; Ritonavir; Zidovudine

Criteria

Inclusion Criteria for Infants:

NOTE: Per Letter of Amendment dated 04/04/07, Part B of this study is no longer recruiting participants. Per Letter of Amendment dated 09/16/08 Arm 1 of this study is longer recruiting.

• HIV infected

• Antiretroviral naive. Infants who have previously received antiretroviral drugs used to prevent mother-to-child transmission are eligible for the study.

• Parent or legal guardian willing to provide informed consent and comply with study requirements

Exclusion Criteria for Infants:

• Any major life-threatening congenital abnormalities

• Severe CDC Stage B or C disease

• Liver enzyme, absolute neutrophil count, hemoglobin, electrolyte, creatinine, or clinical toxicity of Grade 3 or higher at screening

• Any acute or clinically significant medical event that would preclude participation in the study. Randomization can take place as soon as the incurrent illness has resolved if the child is still less than or equal to 12 weeks of age.

• Use of investigational drugs

• Require certain medications. More information on this criterion can be found in the protocol.

• Inability to tolerate oral medication

• Birth weight less than 2 kg (4.4 lbs)