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Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

Primary Purpose

HIV-Associated Lipodystrophy Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
nucleoside analogue sparing HAART regimen
Sponsored by
Danish HIV Research Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-Associated Lipodystrophy Syndrome focused on measuring HIV, Lipoatrophy, Lipodystrophy, Treatment Naive, HIV Infections, Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Antiretroviral naïve patients HIV-1 infection as documented by a licensed HIV-1 antibody ELISA. Fulfilling the criteria for starting antiretroviral therapy. Ability to understand and provide written informed consent. Exclusion Criteria: Women being pregnant or breast-feeding. Fertile women using no safe contraception. Patients with active intravenous drug use. Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol. Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz. Creatinine > 200 mmol/l. ALT or AST > 5 times upper normal value (200U/l).

Sites / Locations

  • Department of Infectious Diseases, Hvidovre University Hospital
  • Department of Infectious Diseases, Aalborg Hospital
  • Department of Infectious Diseases, Aarhus University Hospital
  • Department of Infectious Diseases, Rigshospitalet
  • Department of Infectious Diseases, Odense University Hospital

Outcomes

Primary Outcome Measures

Changes in peripheral fat mass, determined by DEXA-changes
Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
Change from baseline in fasting lipids and subsets hereof
Development of impaired glucose tolerance and insulin resistance

Secondary Outcome Measures

Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks
Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks
Incidence of adverse events
Incidence of clinical disease progression
Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96
Change in plasma lactate from baseline
Time to discontinuation of the randomized therapy and reasons for this
Incidence of genotypical and virological resistance
Development of osteopenia, judged by DEXA-scan
Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96

Full Information

First Posted
August 25, 2005
Last Updated
March 13, 2006
Sponsor
Danish HIV Research Group
Collaborators
Rigshospitalet, Denmark, Hvidovre University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00135460
Brief Title
Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
Official Title
Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Danish HIV Research Group
Collaborators
Rigshospitalet, Denmark, Hvidovre University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Abbott

4. Oversight

5. Study Description

Brief Summary
Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy. The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen. The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-Associated Lipodystrophy Syndrome
Keywords
HIV, Lipoatrophy, Lipodystrophy, Treatment Naive, HIV Infections, Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nucleoside analogue sparing HAART regimen
Primary Outcome Measure Information:
Title
Changes in peripheral fat mass, determined by DEXA-changes
Title
Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
Title
Change from baseline in fasting lipids and subsets hereof
Title
Development of impaired glucose tolerance and insulin resistance
Secondary Outcome Measure Information:
Title
Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks
Title
Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks
Title
Incidence of adverse events
Title
Incidence of clinical disease progression
Title
Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96
Title
Change in plasma lactate from baseline
Title
Time to discontinuation of the randomized therapy and reasons for this
Title
Incidence of genotypical and virological resistance
Title
Development of osteopenia, judged by DEXA-scan
Title
Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Antiretroviral naïve patients HIV-1 infection as documented by a licensed HIV-1 antibody ELISA. Fulfilling the criteria for starting antiretroviral therapy. Ability to understand and provide written informed consent. Exclusion Criteria: Women being pregnant or breast-feeding. Fertile women using no safe contraception. Patients with active intravenous drug use. Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol. Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz. Creatinine > 200 mmol/l. ALT or AST > 5 times upper normal value (200U/l).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Gerstoft, M.D., DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Niels Obel, M.D., DMSc
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Court Pedersen, Professor
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Mathiesen, M.D.,DMSc
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Nielsen, M.D.,DMSc
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Laursen, M.D., DMSc
Organizational Affiliation
Aarhus University City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann-Brit E Hansen, M.D.
Organizational Affiliation
Copenhagen University Hospital Rigshospitalet and Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Infectious Diseases, Hvidovre University Hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Department of Infectious Diseases, Aalborg Hospital
City
Aalborg
Country
Denmark
Facility Name
Department of Infectious Diseases, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Department of Infectious Diseases, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Infectious Diseases, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28399815
Citation
Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naive adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.
Results Reference
derived

Learn more about this trial

Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

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