Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atazanavir+ Ritonavir+ Combivir · 2 trials · 2 indications
Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen
Cmax = maximum observed plasma concentration of atazanavir at specified time points.
Cmax = maximum observed plasma concentration of ritonavir at specified time points.
AUC = area under the concentration curve (AUC \[TAU\]) of atazanavir in one dosing interval from time zero to 24 hours.
AUC = area under the concentration curve (AUC \[TAU\]) of ritonavir in one dosing interval.
Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.
Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.
T 1/2 = terminal elimination half life of atazanavir at specified time points.
T 1/2 = terminal elimination half life of ritonavir at specified time points.
Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.
Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | ARM A: Switch current PI to atazanavir 400 mg once daily plus current \> 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks. Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (\<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily. |
| B | ACTIVE_COMPARATOR | ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus \> 2 NRTIs) for 24 weeks |
| Treatment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Atazanavir | DRUG | atazanavir 400 mg once daily |
| current antiretroviral regimen | DRUG | Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus \> 2 NRTIs |
| Atazanavir + Ritonavir + Combivir | DRUG | Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks |
Inclusion Criteria: * HIV infection * HIV-1 RNA \< 500 copies/ml * Fasting LDL cholesterol \>130 mg/dl OR fasting triglycerides \>200 mg/dl * CD4 count \>100 cells/mm * Stable antiretroviral regimen for at least 12 weeks prior to study entry that includes a protease inhibitor (PI) with or without r...
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Atazanavir is used for the treatment of HIV infections, including HIV in adults and Human Immunodeficiency Virus Type 1 (HIV-1) infection. It is a small molecule developed by Bristol-Myers Squibb Company for the infectious disease therapeutic area.
Atazanavir is a protease inhibitor used against HIV. It works by inhibiting the HIV protease enzyme, which is essential for the virus to mature and become infectious. This mechanism helps reduce viral replication in people with HIV infections.
Atazanavir is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this small molecule for the treatment of HIV infections.
Atazanavir is in Phase 3 clinical development. It is an investigational drug for HIV infections and is not yet approved by regulatory authorities. The development program includes completed trials across multiple phases.
Atazanavir has been studied in clinical trials including NCT00135434, NCT00357240, NCT00365339, and NCT00393328. These trials investigated its effects on glucose and insulin metabolism, drug interactions with proton pump inhibitors and famotidine, and bioequivalence of its 300 mg capsule formulation.
Atazanavir is the generic name for the drug also known as Reyataz. It is an HIV protease inhibitor developed by Bristol-Myers Squibb Company for the treatment of HIV infections in adults.