Trial to investigate etravirine in HIV-1 infected infants and children aged = 2 months to < 6 years

• Conditions: HIV-1 infection; MedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-002630-36-Outside-EU/EEA
• Lead Sponsor: The National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-25
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- A confirmed HIV-1 infection
- Age = 2 months to < 6 years old at study entry.
- HIV-1 RNA viral load > 1000 copies/mL (within the previous 90 days prior to screening) AND an HIV-1 RNA viral load > 1000 copies/mL at screening.
- Treatment experienced children on a failing combination antiretroviral regimen (containing at least 3 ARVs) for at least 8 weeks
OR
Treatment experienced children on a treatment interruption of at least 4 weeks with a history of virologic failure while on a combination antiretroviral regimen (containing at least 3 ARVs)
- Parent or legal guardian able and willing to provide signed informed consent and to have the subject followed at the clinic site
- Availability of sufficient active ARV drugs to create an OBR consistent with protocol requirements
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Evidence of phenotypic resistance to ETR at screening. Phenotypic cutoffs of >10 for loss of sensitivity for cohorts I, II and III.
- Known history of HIV-2 infection in subject or subject’s mother.
- Diagnosis of a new CDC Stage C (per 1994 Revised Classification System for Human Immunodeficiency Virus Infection in Children Less than 13 Years of Age) criteria or opportunistic or bacterial infection diagnosed within 30 days prior to screening and not considered clinically stable.
- Prior history of malignancy.
- Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator’s opinion, would place the subject at an unacceptable risk of injury; render the subject unable to meet the requirements of the protocol; compromise the outcome of this study; or lead to the child being ineligible for participation.
- Current = Grade 3 of any of the following laboratory toxicities at screening: neutrophil count, hemoglobin, platelets, AST, ALT, lipase, serum creatinine.
- Current or anticipated use of any disallowed medications.
- Subject’s family is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate to a non-IMPAACT study site during the study.
- History of non-adherence with ARV medications that in the investigator’s opinion could affect the ability of the subject to comply with the protocol/procedures.
- Grade 3 or higher QTc or PR interval prolongation from the ECG at screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified