The Raltegravir 60+ Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01335620
First received: March 25, 2011
Last updated: May 20, 2014
Last verified: November 2011
  Purpose

This is a phase I, 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.


Condition Intervention Phase
HIV
Drug: Raltegravir
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    maraviroc, darunavir and ritonavir maximum and minimum plasma concentrations will be measured and the time to reach each level

  • Changes in haematology, biochemistry and virology tests [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • cardiovascular disease markers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.

  • Cerebral function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To investigate cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.


Enrollment: 19
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Truvada plus Raltegravir
Single arm study
Drug: Raltegravir
400 mg twice daily
Other Name: Isentress

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335620

Locations
United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Chelsea & Westminster Hospital NHS Trust
London, United Kingdom, SW10 9TH
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Alan Winston, MB BH Imperial College London
Principal Investigator: Marta Boffito Chelsea & Westminster Hospital
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01335620     History of Changes
Other Study ID Numbers: RTG_60, 2010-022907-23
Study First Received: March 25, 2011
Last Updated: May 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on September 11, 2014