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

March 13, 2006 updated by: Danish HIV Research Group

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Department of Infectious Diseases, Aalborg Hospital
      • Aarhus, Denmark, 8200
        • Department of Infectious Diseases, Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Department of Infectious Diseases, Rigshospitalet
      • Odense, Denmark, 5000
        • Department of Infectious Diseases, Odense University Hospital
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, 2650
        • Department of Infectious Diseases, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Incidence of adverse events
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish HIV Research Group

Collaborators

Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Hvidovre University Hospital
Abbott
Aalborg University Hospital

Investigators

  • Study Chair: Jan Gerstoft, M.D., DMSc, Rigshospitalet, Denmark
  • Principal Investigator: Niels Obel, M.D., DMSc, Odense University Hospital
  • Principal Investigator: Court Pedersen, Professor, Odense University Hospital
  • Principal Investigator: Lars Mathiesen, M.D.,DMSc, Hvidovre University Hospital
  • Principal Investigator: Henrik Nielsen, M.D.,DMSc, Aalborg University Hospital
  • Principal Investigator: Alex Laursen, M.D., DMSc, Aarhus University City
  • Principal Investigator: Ann-Brit E Hansen, M.D., Copenhagen University Hospital Rigshospitalet and Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion

November 1, 2007

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2006

Last Update Submitted That Met QC Criteria

March 13, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2612-2198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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