We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Raltegravir 60+ Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01335620
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
HIV Drug: Raltegravir Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Truvada plus Raltegravir
Single arm study
Drug: Raltegravir
400 mg twice daily
Other Name: Isentress


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Day 28 ]
    maraviroc, darunavir and ritonavir maximum and minimum plasma concentrations will be measured and the time to reach each level

  2. 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 Outcome Measures :
  1. cardiovascular disease markers [ Time Frame: 6 months ]
    • To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.

  2. Cerebral function [ Time Frame: 6 months ]
    To investigate cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335620


Locations
United Kingdom
Chelsea & Westminster Hospital NHS Trust
London, United Kingdom, SW10 9TH
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
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

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01335620     History of Changes
Other Study ID Numbers: RTG_60
2010-022907-23 ( EudraCT Number )
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: November 2011

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action