Clinical trial NCT01335620: The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
Official title: An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: HIV
Pharmatokinetic
60 years old
Raltegravir
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 19
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HIV affected over 60 years old
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. HIV-1 infected males or females
2. 60 years of age or greater\*
3. signed informed consent
4. willing to switch therapy as per study protocol
5. no previous exposure to raltegravir or HIV-1 integrase inhibitors
6. plasma HIV RNA \< 50 copies/mL at screening and on at least one other occasion over the last 3 months
7. currently receiving a stable antiretroviral regimen with no antiretroviral drug switches for at least 3 months
8. no previous clinically-significant resistance documented on HIV-1 genotypic resistance
9. subjects in good health upon medical history, physical exam, and laboratory testing
10. BMI above or equal to 18 and below 32
11. Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study.
12. Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance \* 50% of total enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged between 60 and 64 recruited, only subjects aged 65 or over will be eligible.

Exclusion Criteria:

1. current alcohol abuse or drug dependence
2. positive urine drug of abuse screening
3. active opportunistic infection or significant co-morbidities
4. current disallowed concomitant medication

Primary outcomes:
measure: Drug Levels in Blood
timeFrame: Day 28
measure: Changes in Haematology, Biochemistry and Virology Tests
timeFrame: 6 months
Secondary outcomes:
measure: Cardiovascular Disease Markers
timeFrame: 6 months
measure: Cerebral Function; Changes in Global Cognitive Z-score
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Alan Winston, MB BH
role: PRINCIPAL_INVESTIGATOR
affiliation: Chelsea & Westminster Hospital
name: Marta Boffito
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vera JH, Jackson A, Dickinson L, Else L, Barber T, Mora-Peris B, Back D, Boffito M, Winston A. The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age. HIV Clin Trials. 2015 Jan-Feb;16(1):39-42. doi: 10.1179/1528433614Z.0000000006. Epub 2015 Jan 14.