Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
darunavir; ritonavir; emtricitabine/tenofovir · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| arm 1 | EXPERIMENTAL | darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir |
| arm 2 | ACTIVE_COMPARATOR | darunavir, ritonavir, emtricitabine/tenofovir |
| Name | Type | Description |
|---|---|---|
| raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine | DRUG | raltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD. |
| darunavir; ritonavir; emtricitabine/tenofovir | DRUG | darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD. |
Inclusion Criteria: * Patients with acute or primary HIV-1 infection * Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24. * Primary infection: positive Elisa with incomplete Western-blot (≥ 2 ...
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Darunavir/ritonavir/emtricitabine/tenofovir is an investigational combination of small molecules being studied for the treatment of HIV-1 infections. It is currently in Phase 3 clinical development. The combination is being evaluated in patients with HIV-1 infections, with one completed Phase 3 trial involving 90 participants.
Gilead Sciences, Inc. (NASDAQ: GILD) is developing darunavir/ritonavir/emtricitabine/tenofovir. The company is conducting clinical trials for this combination therapy in the treatment of HIV-1 infections. The drug is currently in Phase 3 development.
Darunavir/ritonavir/emtricitabine/tenofovir is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is being studied for the treatment of HIV-1 infections.
Darunavir/ritonavir/emtricitabine/tenofovir has one completed Phase 3 trial, NCT01033760, titled "Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)". This trial enrolled 90 participants with HIV-1 infections in France and was actively controlled, randomized, and biomarker-selected.
Darunavir/ritonavir/emtricitabine/tenofovir is not FDA approved. It is an investigational combination therapy currently in Phase 3 clinical development for HIV-1 infections. The drug has completed one Phase 3 trial, but approval status has not been established.