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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335620
• Other study ID #: RTG_60
• Secondary ID: 2010-022907-23
• Status: Completed
• Phase: Phase 4
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Raltegravir
400 mg twice daily
• Tenofovir
245 mg once daily
• Emtricitabine
200mg once daily

Locations

Country	Name	City	State
United Kingdom	Chelsea & Westminster Hospital NHS Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Levels in Blood	rategravir concentration	Day 28
Primary	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	Cardiovascular Disease Markers	• To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.	6 months
Secondary	Cerebral Function; Changes in Global Cognitive Z-score	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.	6 months