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Optimized Background Therapy · 1 trial · 1 indication
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter \[log10 copies/mL\]). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Optimized Background Therapy (OBT) | DRUG | OBT (3-6 drugs based on treatment history and resistance testing) |
| maraviroc (UK-427,857) | DRUG | maraviroc (UK-427,857) 150 mg taken once daily |
Inclusion Criteria: * Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities) * HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL * Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks * Documented ...
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Optimized Background Therapy is a small molecule regimen being studied for the treatment of HIV Infections. It was evaluated in a Phase 2 clinical trial as a background therapy in combination with maraviroc for antiretroviral-experienced subjects with non-CCR5-tropic HIV-1. The trial enrolled 190 participants across multiple countries.
Optimized Background Therapy is being developed by GSK plc, which trades under the ticker GSK. The company conducted a Phase 2 clinical trial of this therapy in combination with maraviroc for the treatment of HIV Infections in antiretroviral-experienced patients.
Optimized Background Therapy is in Phase 2 clinical development. A Phase 2 trial, NCT00098748, has been completed. The therapy is investigational and has not been approved for use. It was studied as a background regimen in combination with maraviroc for HIV-1 infected subjects.
Optimized Background Therapy was studied in one completed Phase 2 clinical trial, NCT00098748. The trial evaluated maraviroc in combination with Optimized Background Therapy versus Optimized Background Therapy alone in 190 antiretroviral-experienced subjects with non-CCR5-tropic HIV-1 infection. The study was randomized, double-blind, and controlled.
No, Optimized Background Therapy is not the same as maraviroc. In the Phase 2 trial NCT00098748, Optimized Background Therapy was used as the control arm, while maraviroc was the investigational drug added to it. The study compared maraviroc plus Optimized Background Therapy against Optimized Background Therapy alone.