NCT02097108

Brief Summary

This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily. This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 13, 2016

Completed
Last Updated

September 13, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

March 24, 2014

Results QC Date

June 15, 2016

Last Update Submit

July 26, 2016

Conditions

HIV Infections

Keywords

HIV infectionRaltegravirSwitchHyperlipidemiaWomen

Outcome Measures

Primary Outcomes (1)

  • Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction

    A reduction of \> 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or \> 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.

    baseline to week 12

Secondary Outcomes (3)

  • Total Cholesterol Baseline and After 24 Weeks

    baseline to week 24

  • Triglycerides Baseline and After 24 Weeks

    baseline to week 24

  • High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks

    baseline to week 24

Study Arms (1)

Raltegravir

OTHER

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Drug: Raltegravir

Interventions

RaltegravirDRUG
Raltegravir

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented HIV-1 infection in female patients, age ≥18 years
  • Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months
  • Plasma HIV viral load \<50 copies/ml on current boosted PI containing regimen for ≥ 6 months prior to study entry
  • Fasting LDL cholesterol \>130 mg/dl
  • Fasting triglycerides \<450 mg/dl

You may not qualify if:

  • History of virological failure during previous antiretroviral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PMU Salzburg

Salzburg, 5020, Austria

Location

AKH Wien

Vienna, 1090, Austria

Location

Ottto Wagner Spital

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

HIV InfectionsHyperlipidemias

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Public contact Daniela Wolkersdorfer
Organization
AGMT
d.wolkersdorfer@agmt.at
00436626404411

Study Officials

  • Richard Greil, MD

    PMU Salzburg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 26, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 13, 2016

Results First Posted

September 13, 2016

Record last verified: 2016-07

Locations

AU(3)