Phase 4
Completed N=19
The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
Source: ClinicalTrials.gov NCT01335620 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Drug Levels in Blood — 1732 ng/ml
◆ Published Evidence
Emerging
12citations · ~1 / year
The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age.
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.
Linked Publications
-
The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Levels in Blood |
1732 | — |
| PRIMARY Changes in Haematology, Biochemistry and Virology Tests |
— | — |
| SECONDARY Cardiovascular Disease Markers |
— | — |
| SECONDARY Cerebral Function; Changes in Global Cognitive Z-score |
0.91 | 0.018 sig |
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected males or females
- 60 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.
Exclusion Criteria
- current alcohol abuse or drug dependence
- positive urine drug of abuse screening
- active opportunistic infection or significant co-morbidities
- current disallowed concomitant medication
Data sourced from ClinicalTrials.gov (NCT01335620) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.