Last reviewed · How we verify
Optimized Background Regimen
An optimized antiretroviral background regimen designed to enhance the efficacy of leronlimab (a CCR5 antagonist) in HIV treatment.
An optimized antiretroviral background regimen designed to enhance the efficacy of leronlimab (a CCR5 antagonist) in HIV treatment. Used for HIV-1 infection (as background regimen component in clinical trials).
At a glance
| Generic name | Optimized Background Regimen |
|---|---|
| Also known as | Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history., OBT, enfuvirtide, antiretroviral therapy, OBR |
| Sponsor | CytoDyn, Inc. |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
This is a standardized combination antiretroviral therapy backbone used in clinical trials with leronlimab, typically consisting of nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and other agents selected to provide optimal viral suppression while allowing assessment of leronlimab's additional benefit. The regimen is tailored to individual patient resistance profiles and treatment history.
Approved indications
- HIV-1 infection (as background regimen component in clinical trials)
Common side effects
Key clinical trials
- Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis (PHASE1)
- Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance (PHASE2, PHASE3)
- Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children (PHASE2)
- Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-Infected and HIV-Uninfected Children With MDR-TB (PHASE1, PHASE2)
- Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France
- Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease (PHASE2, PHASE3)
- Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients (PHASE2)
- Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Optimized Background Regimen CI brief — competitive landscape report
- Optimized Background Regimen updates RSS · CI watch RSS
- CytoDyn, Inc. portfolio CI