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The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age

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
Results First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
HIV Drug: Raltegravir Drug: Tenofovir Drug: Emtricitabine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: HIV affected over 60 years old
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
Actual Study Start Date : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Tenofovir/Emtricitabine and Raltegravir

Single arm study

tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily

Drug: Raltegravir
400 mg twice daily
Other Name: Isentress

Drug: Tenofovir
245 mg once daily

Drug: Emtricitabine
200mg once daily




Primary Outcome Measures :
  1. Drug Levels in Blood [ Time Frame: Day 28 ]
    rategravir concentration

  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; Changes in Global Cognitive Z-score [ Time Frame: 6 months ]

    Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.

    Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion.




Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Alan Winston, MB BH Imperial College London
Principal Investigator: Marta Boffito Chelsea & Westminster Hospital
Publications of Results:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01335620    
Other Study ID Numbers: RTG_60
2010-022907-23 ( EudraCT Number )
First Posted: April 14, 2011    Key Record Dates
Results First Posted: November 20, 2019
Last Update Posted: November 20, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
HIV
Pharmatokinetic
60 years old
Raltegravir
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Raltegravir Potassium
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors