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

NCT01335620 | Completed Phase 4 Results

• 2 other identifiers: RTG_602010-022907-23
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Keywords

HIV; Pharmatokinetic; 60 years old; Raltegravir

Outcome Measures

Primary Outcomes (2)

• Drug Levels in Blood

  rategravir concentration

  Day 28

• Changes in Haematology, Biochemistry and Virology Tests

  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

  6 months

Secondary Outcomes (2)

• Cardiovascular Disease Markers

  6 months

• Cerebral Function; Changes in Global Cognitive Z-score

  6 months

Study Arms (1)

Tenofovir/Emtricitabine and Raltegravir

OTHER

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

Drug: Raltegravir; Drug: Tenofovir; Drug: Emtricitabine

Interventions

Raltegravir DRUG

400 mg twice daily

Also known as: Isentress

Tenofovir/Emtricitabine and Raltegravir

Tenofovir DRUG

245 mg once daily

Tenofovir/Emtricitabine and Raltegravir

Emtricitabine DRUG

200mg once daily

Tenofovir/Emtricitabine and Raltegravir

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infected males or females
• 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
• 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.
• 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.

You may not qualify if:

• current alcohol abuse or drug dependence
• positive urine drug of abuse screening
• active opportunistic infection or significant co-morbidities
• current disallowed concomitant medication

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Chelsea & Westminster Hospital NHS Trust

London, SW10 9TH, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25777188 RESULT

MeSH Terms

Interventions

Raltegravir Potassium; Tenofovir; Emtricitabine

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Alan Winston
• Organization: Imperial College London

a.winston@imperial.ac.uk

+442033121603

Study Officials

• Alan Winston, MB BH

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Marta Boffito

  Chelsea & Westminster Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HIV affected over 60 years old

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)