Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
- Conditions
- HIV InfectionsMedDRA version: 17.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-005134-64-Outside-EU/EEA
- Lead Sponsor
- Bristol-Myers Squibb Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 195
For step 1:
- Age: 91 days to 180 days of age.
- A confirmed diagnosis of HIV infection defined by the current definition of the IMPAACT Virology Core Laboratory Committee. The current (April 00) definition requires two separate peripheral blood specimens from different days, and each specimen must be positive. The two positive results may be obtained in any combination of the following:
• at any age: HIV culture, HIV-DNA PCR, or Plasma HIV RNA value > 10,000 copies/mL
• age >4 weeks: neutralizable HIV p24 antigen (regular or ICD)
• age >18 months: licensed ELISA with confirmatory Western Blot
This definition may be updated by the IMPAACT Virology Core Laboratory Committee at any time. The IMPAACT P1020A will update the sites if these assays or their combination is modified. The protocol will always use the current definition of confirmed HIVinfection.
- Viral load = 5,000 copies/mL
- Any CDC clinical classification and immune status.
- Antiretroviral treatment naïve or experienced study candidates must be able to add two new NRTIs as part of their new therapy in this protocol, or have genotypic evidence of sensitivity to two NRTIs (the NRTIs must be used in combinations recommended in the Guidelines for the Use of Antiretroviral Agents in Pediatric and Adolescent HIV
Infection).
If the study candidate has previously received treatment with ddC, ddI will not be considered a new NRTI for his/her new regimen under this protocol, and vice-versa.
Abacavir sulfate (ABC, Ziagen®) and tenofovir disoproxil fumarate (TDF, Viread®) will be excluded as NRTI options for the subject’s regimen.
Sites must send an e-mail to the protocol team at actg.teamp1020@fstrf.org , establishing the candidate's PID#, date of
birth (DOB), and ART-history. This information is required to determine if genotypic testing is needed. Sites must receive
authorization, for each candidate, from the protocol team before proceeding with screening.
- Study candidates must show evidence of retained phenotypic sensitivity to BMS-232632 (resistance index ratio of less than 10) when the subject has failed (after at least 12 weeks of therapy) two or more courses of PI containing regimens.
Sites must send an e-mail to the protocol team at actg.teamp1020@fstrf.org , establishing the candidate's PID#, date of
birth (DOB), and ART-history. This information is required to determine if phenotypic testing is needed to confirm eligibility. Sites must receive authorization, for each candidate, from the protocol team before proceeding with screening.
- Demonstrated ability and willingness to swallow study medications.
- Study candidate, parent or legal guardian able and willing to provide signed informed consent.
- Female participants who are sexually active and able to become pregnant must use two methods of birth control. Hormonal birth control alone (e.g. pills, shots, or slow release inserts placed under the skin) would not be considered adequate. An effective, medically accepted barrier method of contraception [e.g., female/male condoms, diaphragm or cervical cap with a cream or gel that kills sperm, intrauterine device (IUD), others] must also be used during
the study. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission. Use of an IUD may increase the risk of pelvic inflammatory disease.
- Males participating in the study must not attempt to impregnate a female, or participate in sperm
For Step 1:
- Active hepatitis.
- Presence of an acute serious/invasive infection requiring therapy at the time of enrollment.
- Hypersensitivity to any component of the formulation of BMS-232632.
- Chemotherapy for active malignancy.
- Pregnancy or breastfeeding.
- Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the clinician's opinion, would compromise the outcome of this study.
- Any laboratory or clinical toxicity > Grade 2 at entry
- Documented history of cardiac conduction abnormalities, or significant cardiac dysfunction.
- History of undefined syncope that can not be ruled out as related to cardiac conduction abnormalities6.
- Family history of prolonged QTc-interval syndrome, Brugada syndrome, or right-ventricular (RV) dyplasia.
- Corrected QTc-Interval > 440 msec at screening.
- Prolonged PR-Interval >0.200 seconds (200 ms) on ECG at screening (Study candidates =13 years of age).
- PR-Interval > 98th percentile on ECG at screening (Study candidates <13 years of age). Use Appendix VIII Table to Determine 98th Percentile for PR-Intervals in Subjects < 13 of Age”.
- Cardiac rhythm abnormalities:
• A type I second-degree atrioventricular (AV) block (Mobitz type I heart-block) occurring during waking hours on ECG at
screening.
• A type II second-degree AV-block (Mobitz type II heart-block) at any time on ECG at screening.
• A complete AV-block at any time on ECG at screening.
• A heart rate less than the 2nd percentile for age of the normal heart rate range (See Appendix IX) on ECG at screening.
- Prolonged therapy with intravenous pentamidine for acute Pneumocystis Carinii Pneumonia (PCP) within three months of entry.
For Step 2:
- A South African subject who meets any of the criteria for treatment discontinuation by Week 96 of the last subject enrolled into either part of Step I (see Section 6.4 Criteria for Treatment Discontinuation).
- A South African subject who meets any of the exclusion criteria (Section 4.2) from Step I by Week 96 of the last subject enrolled into either part of Step 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method