Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Abacavir sulfate; Didanosine; Efavirenz; Lamivudine; Lopinavir/Ritonavir; Nevirapine; Zidovudine
Intervention description: Second Line Regimen: 8 mg/kg taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.; Second Line Regimen: Either 100 mg/m^2 or 120 mg/m^2 taken orally twice daily. Dosage depends on age. Guidelines for switching from first line to second line therapy are available in the protocol.; Second Line Regimen: taken orally once daily. Dosage depends on weight. Guidelines for switching from first line to second line therapy are available in the protocol.; First Line Regimen: 4 mg/kg taken orally twice daily; First Line Regimen: taken orally twice daily. Dosage depends on age and weight.; Second Line Regimen: 150 - 200 mg/m^2 taken orally twice daily. Guidelines for switching from first line to second line therapy are available in the protocol.; First Line Regimen: 240 mg/m^2 taken orally twice daily
Intervention MeSH terms: Ritonavir; Lopinavir; Lamivudine; Zidovudine; Nevirapine; Abacavir; Didanosine; Efavirenz
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study had two parts: Part A where children were enrolled with CD4% ≥ 25% and Part B where children were enrolled with CD4% < 25%. Part A had three arms: ART-Deferred, ART-40W and ART-96W where ART-40W and ART-96W were the early therapy arms for 40 and 96 weeks respectively. Part B were enrolled into two Arms: ART-40W and ART-96W. The primary efficacy analysis for CHER was based on 377 children that were enrolled in Part A in the first phase of the study. The NIH African data safety and monitoring board recommended that primary analysis be focussed on 377 children enrolled in the first phase of Part A. Additionally, all the key manuscripts have been analysed using this group. Hence all the results presented in clinicaltrials.gov will be specific to this group with three arms.
Masking: None (Open Label)
Enrollment: 377.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: No
Keywords: Infant; Perinatal; HIV; Disease Transmission, Vertical; Anti-Retroviral Agents; Treatment Interruption; Treatment Naive; Acute Infection; Mother-to-Child Transmission

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.
    

Eligibility 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)