Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01099579 | PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV) | PHASE3 | COMPLETED | 82 | — | — | Oct 13, 2010 | Sep 11, 2017 | May 24, 2018 | 18 | Brazil, Chile +4 |
| NCT00135395 | A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen | PHASE3 | COMPLETED | 200 | — | — | May 1, 2004 | Feb 1, 2006 | Feb 5, 2010 | 53 | United States, Puerto Rico |
| NCT00067782 | A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy | PHASE3 | COMPLETED | - | — | — | Dec 1, 2002 | Mar 1, 2005 | Apr 14, 2011 | 19 | United States |
| NCT00035932 | Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV | PHASE3 | COMPLETED | 571 | — | — | Nov 1, 2001 | Mar 1, 2009 | Dec 24, 2010 | 29 | United States |
| NCT00013897 | A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine | PHASE3 | COMPLETED | - | — | — | Feb 1, 2001 | Apr 1, 2003 | May 4, 2011 | 99 | United States, Austria +22 |
| NCT00028301 | Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s) | PHASE3 | COMPLETED | - | — | — | Feb 1, 2001 | Sep 1, 2003 | Sep 13, 2010 | 97 | United States, Argentina +14 |
| NCT00004584 | Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment | PHASE2 | COMPLETED | - | — | — | Dec 1, 1999 | Jan 1, 2002 | May 4, 2011 | 38 | United States, Canada +3 |
| NCT00002240 | Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs | PHASE2 | COMPLETED | - | — | — | Mar 1, 1999 | Dec 1, 2001 | May 4, 2011 | 17 | United States, Canada |
| NCT00393328 | Bioequivalence Study of Atazanavir 300 mg Capsule | PHASE1 | COMPLETED | 46 | — | — | Nov 1, 2006 | Dec 1, 2006 | Apr 8, 2011 | 1 | United States |
| NCT00357240 | Drug Interaction Study With Proton Pump Inhibitor | PHASE1 | COMPLETED | 56 | — | — | Jun 1, 2006 | Aug 1, 2006 | Apr 8, 2011 | 1 | United States |
| NCT00365339 | Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir | PHASE1 | COMPLETED | 40 | — | — | Apr 1, 2006 | Jun 1, 2006 | Apr 8, 2011 | 1 | United States |
| NCT00135434 | Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism | PHASE1 | COMPLETED | 25 | — | — | Sep 1, 2004 | Jun 1, 2005 | Apr 8, 2011 | 1 | United States |
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=\<6.5. Neutrophils, absolute (/mm\^3): Gr 1=\>=1000-\<1500; Gr 2= \>=750-\<1000; Gr 3=\>=500-\<750; Gr 4=\<500. ALT/SGPT (\*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=\>10. AST/SGOT (\*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=\>10. Alkaline phosphatase(\*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5: Gr 3=5.1-10; Gr 4=\>10. Total bilirubin (\*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=\>5. Amylase (\*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=\>5.0. Lipase (\*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=\>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=\>15.
Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds.
CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (\>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (\>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss \>10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.
| Arm | Type | Description |
|---|---|---|
| Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg | EXPERIMENTAL | Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of ≥25kg transitioned from the powder to the capsule formulation of ATV. Patients who weighed 15 to \<20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to \<40 kg received ATV, 200 mg, and RTV, 100 mg; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake. |
| Atazanavir powder, 200 mg/Ritonavir oral solution, 80 mg | EXPERIMENTAL | Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of ≥25kg transitioned from the powder to the capsule formulation of ATV. Patients who weighed 15 to \<20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to \<40 kg received ATV, 200 mg, and RTV, 100 mg; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake. |
| Atazanavir powder, 250 mg/Ritonavir oral solution, 80 mg | EXPERIMENTAL | Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of ≥25kg transitioned from powder to the capsule formulation of ATV. Patients who weighed 15 to \<20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to \<40 kg received ATV, 200 mg, and RTV, 100 mg; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake. |
| A | ACTIVE_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| 1 | ACTIVE_COMPARATOR | - |
| 2 | ACTIVE_COMPARATOR | - |
| I | ACTIVE_COMPARATOR | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| II | ACTIVE_COMPARATOR | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| III | ACTIVE_COMPARATOR | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| A1 | ACTIVE_COMPARATOR | - |
| A2 | ACTIVE_COMPARATOR | - |
| A3 I | EXPERIMENTAL | - |
| A3 II | EXPERIMENTAL | - |
| B1 | ACTIVE_COMPARATOR | - |
| B2 | ACTIVE_COMPARATOR | - |
| B3 I | EXPERIMENTAL | - |
| B3 II | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | EXPERIMENTAL | - |
| E | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Atazanavir powder | DRUG | Powder, oral, dosed by weight. Participants who weighed 5 to \<10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to \<15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to \<25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation. |
| Ritonavir oral solution | DRUG | Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation. |
| Atazanavir capsules | DRUG | Capsules, oral, dosed by weight in Stage 2. Patients who reached the age of 6 years or a weight of ≥25 kg transitioned from the powder to the capsule formulation of atazanavir (ATV). Patients who weighed 15 to \<20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to \<40 kg received ATV, 200 mg, and RTV, 100 mg; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake. |
| Ritonavir capsules | DRUG | Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight. |
| Atazanavir+ritonavir | DRUG | Capsules, Oral, 300mg/100mg, once daily, 24 weeks. |
| Lopinavir+ritonavir | DRUG | Capsules, Oral, 800mg/200mg, twice daily, 24 weeks. |
| Atazanavir (immediate switch) | DRUG | Capsules, Oral, 400mg, Once daily, 48 weeks. |
| Atazanavir (Week 24 switch) | DRUG | Capsules, Oral, 400mg, Once daily, 48 weeks. |
| Atazanavir + ritonavir + tenofovir + nucleoside | DRUG | Active Comparator, Capsules, tablets, Oral |
| Atazanavir + saquinavir + tenofovir + nucleoside | DRUG | Active Comparator, Capsules, tablets, Oral |
| Lopinavir/ritonavir + tenofovir + nucleoside | DRUG | Active Comparator, Capsules, tablets, Oral |
| Atazanavir | DRUG | - |
| Lamivudine/Zidovudine | DRUG | - |
| Efavirenz | DRUG | - |
| Lopinavir/Ritonavir | DRUG | - |
| Ritonavir | DRUG | - |
| Saquinavir | DRUG | - |
| Nelfinavir mesylate | DRUG | - |
| Stavudine | DRUG | - |
| Didanosine | DRUG | - |
| Atazanavir + Ritonavir | DRUG | Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B. |
| Atazanavir/Ritonavir | DRUG | Capsules/capsules, Oral, 300/100 mg, once daily, 10 days. |
| Atazanavir/Ritonavir+Omeprazole | DRUG | Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. |
| Atazanavir+Ritonavir+Tenofovir | DRUG | Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days. |
| Atazanavir+Ritonavir+Tenofovir+Famotidine | DRUG | Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days. |
| Atazanavir/Ritonavir/Lopinavir/ritonavir | DRUG | - |
Key Inclusion Criteria: * Confirmed human immunodeficiency virus (HIV)-1 infection diagnosed by a positive virologic test result on 2 separate occasions by: * HIV DNA polymerase chain reaction * HIV RNA with values ≥1,000 copies/mL * Positive HIV enzyme-linked immunosorbent assay at ≥18 mont...