Safety and Immune Response to Vicriviroc in Combination Regimens in HIV-Infected ART Experienced Children and Adolescents

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Complications with current HIV antiretroviral therapy have left many children and adolescents with limited therapeutic options due to drug resistance. The purpose of this study is to test the effectiveness and safety of Vicriviroc (VCV), an HIV entry inhibitor and CCR5 co-receptor antagonist.

• 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)

Criteria

Inclusion Criteria:

• Confirmed HIV infection

• Treatment experienced subjects: Children or adolescents on an unchanged therapeutic regimen for at least 12 weeks and experiencing virologic failure OR participants on no treatment for 4 weeks or more but with history of virologic failure on a prior therapeutic regimen.

• Likely to have virus that is sensitive to at least one ritonavir boosted protease inhibitor

• HIV viral load greater than or equal to 1,000 copies/ml within 90 days prior to Step I entry

• Able to swallow study medication, in tablets or liquid form specific to age-assigned cohort

• Parent, legal guardian or participant able and willing to provide signed informed consent and to have the participant followed at the clinic site

• Willing to use effective methods of contraception

Inclusion Criteria for Step II (In addition to the inclusion criteria for Step I):

• Participant's plasma HIV tested at Step I must be R5 tropic

• Genotypic sensitivity enabling the participant to take optimized background therapy (OBT) consisting of at least a ritonavir-based protease inhibitor. More information on this criterion can be found in the study protocol.

Exclusion Criteria:

• Presence of any currently active AIDS defining illness or history of malignancy

• History of a seizure disorder that requires current anti-seizure medication for control or at risk for seizures. Those with a history of febrile seizures alone are not excluded.

• Certain abnormal laboratory values. More information on this criterion can be found in the protocol.

• Any vaccinations 14 days prior to Step I, or scheduled to occur within 14 days prior to entry into Step II, and the week 24 and 48 visits in Step II

• Allergy or sensitivity to study drug or its ingredients

• Taking any Step II disallowed medications (see protocol) and unable or unwilling to discontinue them at least one week prior to entering Step II

• Use of NNRTIs other than etravirine 21 days prior to Step II entry

• Pregnancy or breastfeeding. Infants who are receiving breastmilk are allowed to enroll.

Exclusion Criteria for Step II

• All exclusion criteria for Step I

• Participants harboring dual or mixed tropic virus (R5/X4) or X4 virus or non phenotypable virus

• Current or anticipated use of any disallowed medications

• Use of efavirenz, nevirapine, and delavirdine for 21 days prior to Step II entry

• Pregnant within 3 days of Step II entry