Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atazanavir Sulphate · 1 trial · 1 indication
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) |
| Name | Type | Description |
|---|---|---|
| Atazanavir Sulphate | DRUG | - |
| Ritonavir | DRUG | - |
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 is an investigational small molecule being developed for the treatment of HIV and HIV Infections. It is currently in Phase 3 clinical development. The drug is being studied in combination with other antiretroviral agents, such as ritonavir, to manage HIV infection in affected patients.
Atazanavir Sulphate is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infections, with the most advanced study being a Phase 3 trial.
Atazanavir Sulphate is in Phase 3 clinical development for the treatment of HIV. The most advanced trial is a Phase 3 study evaluating the drug's effects in HIV-infected pediatric patients. This trial has been completed, and the drug remains investigational, not yet approved by regulatory authorities.
Atazanavir Sulphate has been studied in three completed clinical trials. These include NCT00357188 and NCT00357721, both Phase 1 studies in healthy subjects, and NCT01335698, a Phase 3 study in HIV-infected pediatric patients. The Phase 3 trial enrolled 160 participants across multiple countries.
Atazanavir Sulphate is a protease inhibitor used in the treatment of HIV. It works by inhibiting the HIV protease enzyme, which is essential for the virus to replicate. By blocking this enzyme, the drug prevents the virus from maturing and infecting new cells, thereby reducing viral load in patients.