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Kaletra · 3 trials · 1 indication
Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interaction term in the model will indicate the difference in viral decay rates between the two treatment groups. Baseline covariate adjustment will be included if necessary.
| Arm | Type | Description |
|---|---|---|
| 1 - Kaletra + Isentress taken twice daily | EXPERIMENTAL | Kaletra (lopinavir/ritonavir 400/100 mg) + Isentress (Raltegravir 400 mg) twice-daily |
| 2 - Atripla taken once daily | ACTIVE_COMPARATOR | Sustiva (EFV 600 mg), Viread (TDF 300 mg) and Emtriva (FTC 200 mg) taken as Atripla® once-daily |
| 1 | EXPERIMENTAL | Kaletra (lopinavir/ritonavir) |
| 2 | ACTIVE_COMPARATOR | Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine) |
| Name | Type | Description |
|---|---|---|
| Kaletra + Isentress | DRUG | kaletra 2 tabs twice a day + Raltegravir 1 tab twice a day |
| Atripla | DRUG | Atripla 1 tab once a day |
| Kaletra (lopinavir/ritonavir) | DRUG | (200/50 mg x2)x 2/d= 2 pills twice daily |
| Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine) | DRUG | Kaletra (lopinavir/ritonavir): (200/50 mg x2)x 2/d= 2 pills twice daily Combivir (zidovudine/lamivudine): (300/150mg) x 2/d=1 pill twice daily |
| Kaletra® (lopinavir/ritonavir) | DRUG | - |
| Combivir® (lamivudine, zidovudine) | DRUG | - |
| Sustiva® (efavirenz) | DRUG | - |
Inclusion Criteria: * Documented HIV-1 infection. * Treatment naïve (defined as having never received any HIV antiretroviral agents in past). * CD4+ T-cell count greater than or equal to 50 cells/mm3 * HIV viral load greater than or equal to 5,000 copies/mL * Laboratory values obtained by screening...
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Kaletra is a small molecule drug being developed for the treatment of HIV Infections. It is a combination of lopinavir and ritonavir, and it is currently in Phase 2 clinical development. The drug is being studied in previously untreated HIV-infected patients and in the prevention of mother-to-child transmission of HIV.
Kaletra contains lopinavir and ritonavir, which are protease inhibitors. These drugs target the HIV protease enzyme, which is essential for the virus to mature and become infectious. By inhibiting this enzyme, Kaletra helps to reduce the viral load in patients with HIV Infections.
Kaletra is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker symbol ABT. The drug is currently in Phase 2 clinical trials for the treatment of HIV Infections.
Kaletra is in Phase 2 clinical development for the treatment of HIV Infections. It is an investigational drug and has not yet been approved by regulatory authorities. All three clinical trials for Kaletra have been completed, with a total enrollment of 306 participants.
Kaletra has been studied in three completed Phase 2 clinical trials. These include NCT00075231, which compared Kaletra-based therapy to efavirenz-based standard of care in untreated HIV patients, NCT00424814, which studied prevention of mother-to-child HIV transmission, and NCT00752856, which compared raltegravir plus Kaletra to efavirenz plus tenofovir and emtricitabine.
Kaletra is a combination drug that contains lopinavir and ritonavir. It is often referred to by its components, lopinavir/ritonavir. The drug is being developed by Abbott Laboratories and is currently in Phase 2 clinical trials for HIV Infections.