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Label indication REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4) ] . FDA label
Also known as Atazanavir Sulphate, Reyataz
Atazanavir Sulphate+ Ritonavir · 4 trials · 3 indications
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention \[eg, medical, surgical\] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization
The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: \<200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.
Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants \>7 days): Gr 1=1.000-1300/mm\^3; Gr 2=750-999 mm\^3; Gr 3=500-749 mm\^3; Gr 4= \<500 mm\^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5\*upper limit of normal (ULN); Gr 2=2.6-5.0\*ULN; Gr 3=5.1-10.0\*ULN; Gr 4= \>10.0\*ULN. Bilirubin, total (adults and infants \>14 days): Gr 1=1.1-1.5\*ULN; Gr 2=1.6-2.5\*ULN; Gr 3=2.6-5.0\*ULN; Gr 4= \>5.0\*ULN. Lipase: Gr 1=1.1-1.5\*ULN; Gr 2=1.6-3.0\*ULN; Gr 3=3.1-5.0\*ULN; Gr 4= \>5.0\*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-\<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= \<8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39\*ULN; Gr 2=1.40-2.09\*ULN; Gr 3.=2.10-5.0\*ULN; Gr 4= \>5.0\*ULN.
| Arm | Type | Description |
|---|---|---|
| Stage 1: Atazanavir + Ritonavir | EXPERIMENTAL | Participants received atazanavir powder orally (dosed by weight: 5 to \<10 kg=150 mg, 5 to \<10 kg=200 mg, 10 to \<15 kg=200 mg, 15 to \<25 kg=250 mg, 25 to \<35 kg=300 mg) once daily for 24 to 48 weeks or a weight ≥35 kg. Participants also received ritonavir once daily for 24 to 48 weeks or weight ≥35 kg in the form of 80-mg/mL solution, orally (dosed by weight 5 to \<25 kg=80 mg, 25 to \<35 kg=100 mg); 100-mg capsule, orally (dosed by weight 25 to \<35 kg=100 mg); or 100-mg tablet, orally (dosed by weight 25 to \<35 kg=100 mg) |
| A | ACTIVE_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| C | ACTIVE_COMPARATOR | - |
| D | ACTIVE_COMPARATOR | - |
| E | ACTIVE_COMPARATOR | - |
| A1 | ACTIVE_COMPARATOR | - |
| A2 | ACTIVE_COMPARATOR | - |
| A3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Atazanavir Sulphate | DRUG | - |
| Ritonavir | DRUG | - |
| Rosiglitazone maleate | DRUG | Tablets, Oral, RGZ 4 mg, once daily, 1 day. |
| Atazanavir Sulphate + Rosiglitazone maleate | DRUG | Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day. |
| Atazanavir Sulphate + Ritonavir | DRUG | Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days. |
| Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate | DRUG | Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day. |
| Atazanavir Sulphate + Ritonavir + Efavirenz | DRUG | Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days. |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Key Inclusion Criteria: * Confirmed HIV-1 infection diagnosed by protocol criteria * Screening HIV RNA level ≥1000 copies/mL * ≥3 months to \<11 years of age at time of first treatment * Antiretro...
Atazanavir Sulphate + Ritonavir is a combination antiretroviral therapy used for the treatment of HIV and HIV infections. It combines atazanavir sulphate with ritonavir, which is used as a pharmacokinetic booster. The combination is studied in both adult and pediatric patients living with HIV.
Atazanavir Sulphate + Ritonavir is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the sponsor of the clinical trials evaluating this combination.
Atazanavir Sulphate + Ritonavir is in Phase 3 clinical development. The Phase 3 trial is a Phase IIIB study evaluating the effects of atazanavir powder with ritonavir in HIV-infected pediatric patients. The drug is investigational and has not been approved by the FDA for this use.
Atazanavir Sulphate + Ritonavir has been studied in four completed clinical trials. The Phase 3 trial is NCT01335698, a Phase IIIB study in HIV-infected pediatric patients. Earlier Phase 1 trials include NCT00362726, NCT00357721, and NCT00357188, which examined drug interactions, twice-daily dosing, and dose finding.
Atazanavir Sulphate + Ritonavir is a combination product that includes atazanavir sulphate plus ritonavir. It is also known as Atazanavir Sulphate + Ritonavir or simply Atazanavir Sulphate. The addition of ritonavir distinguishes it from atazanavir sulphate used alone.