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Optimized Background Therapy

Phase 2

HIV Infections | Small molecule | Infectious Disease |GSK plc|Trials Updated: Dec 7, 2010

Optimized Background Therapy development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Dec 2004

Optimized Background Therapy target and mechanism

ModalitySmall molecule

Also known as Optimized Background Therapy (OBT)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

Optimized Background Therapy clinical trials

Optimized Background Therapy · 1 trial · 1 indication

Phase 2 1
NCT00098748Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected SubjectsHIV Infections
COMPLETED190 Analytics
PHASE2COMPLETED
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Human Immunodeficiency Virus (HIV-1) Viral Load (Ribonucleic Acid [RNA])
Baseline to Week 24 and Week 48

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.

Secondary Endpoints

Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL
Week 24, Week 48
Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 0.5 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels
Baseline, Week 24, Week 48
Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 1.0 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels
Baseline, Week 24, Week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -

Interventions

NameTypeDescription
Optimized Background Therapy (OBT)DRUGOBT (3-6 drugs based on treatment history and resistance testing)
maraviroc (UK-427,857)DRUGmaraviroc (UK-427,857) 150 mg taken once daily
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites77

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 ...

Countries:United StatesAustraliaBelgiumCanadaGermanyNetherlandsSpainSwitzerlandUnited Kingdom
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Frequently asked questions about Optimized Background Therapy

What is Optimized Background Therapy (OBT) used for?

Optimized Background Therapy (OBT) is used in the treatment of HIV Infections. In clinical research, OBT refers to a customized combination of antiretroviral drugs selected for an individual patient based on their prior treatment history and resistance profile, serving as the background regimen to which an investigational agent is added.

Who is developing Optimized Background Therapy (OBT)?

GSK plc (ticker: GSK) is the developer associated with Optimized Background Therapy (OBT). The company sponsored a Phase 2 trial evaluating OBT in combination with maraviroc (UK-427,857) versus OBT alone in antiretroviral-experienced, non-CCR5-tropic HIV-1 infected subjects.

What phase is Optimized Background Therapy (OBT) in?

Optimized Background Therapy (OBT) has been studied in a Phase 2 clinical trial. It is an investigational approach and is not an approved standalone product. The Phase 2 study has been completed, and no active trials of OBT are currently listed.

What clinical trials is Optimized Background Therapy (OBT) in?

Optimized Background Therapy (OBT) was evaluated in the completed Phase 2 trial NCT00098748, titled "Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects." The trial enrolled 190 participants across the United States, Australia, Belgium, Canada, Germany, Netherlands, Spain, Switzerland, and the United Kingdom.

Is Optimized Background Therapy (OBT) the same as Optimized Background Therapy?

Yes, Optimized Background Therapy (OBT) is the same as Optimized Background Therapy. OBT is simply the abbreviated form of the full term. Both refer to the same concept used in HIV treatment and clinical trial design.