An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
Overview
- Phase
- Phase 4
- Intervention
- Raltegravir
- Conditions
- HIV
- Sponsor
- Imperial College London
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Drug Levels in Blood
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.
Detailed Description
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study. Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing. At baseline, subjects will switch antiretroviral therapy to: * tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus * raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit. Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken. Following completion of this study, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV-1 infected males or females
- •60 years of age or greater\*
- •signed informed consent
- •willing to switch therapy as per study protocol
- •no previous exposure to raltegravir or HIV-1 integrase inhibitors
- •plasma HIV RNA \< 50 copies/mL at screening and on at least one other occasion over the last 3 months
- •currently receiving a stable antiretroviral regimen with no antiretroviral drug switches for at least 3 months
- •no previous clinically-significant resistance documented on HIV-1 genotypic resistance
- •subjects in good health upon medical history, physical exam, and laboratory testing
- •BMI above or equal to 18 and below 32
Exclusion Criteria
- •current alcohol abuse or drug dependence
- •positive urine drug of abuse screening
- •active opportunistic infection or significant co-morbidities
- •current disallowed concomitant medication
Arms & Interventions
Tenofovir/Emtricitabine and Raltegravir
Single arm study tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily
Intervention: Raltegravir
Tenofovir/Emtricitabine and Raltegravir
Single arm study tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily
Intervention: Tenofovir
Tenofovir/Emtricitabine and Raltegravir
Single arm study tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily
Intervention: Emtricitabine
Outcomes
Primary Outcomes
Drug Levels in Blood
Time Frame: Day 28
rategravir concentration
Changes in Haematology, Biochemistry and Virology Tests
Time Frame: 6 months
full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus
Secondary Outcomes
- Cerebral Function; Changes in Global Cognitive Z-score(6 months)
- Cardiovascular Disease Markers(6 months)