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

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ClinicalTrials.gov Identifier: NCT00135460
Recruitment Status : Unknown
Verified September 2005 by Danish HIV Research Group.
Recruitment status was:  Active, not recruiting
First Posted : August 26, 2005
Last Update Posted : March 14, 2006
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HIV-Associated Lipodystrophy Syndrome Drug: nucleoside analogue sparing HAART regimen Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2003
Estimated Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Changes in peripheral fat mass, determined by DEXA-changes
  2. Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
  3. Change from baseline in fasting lipids and subsets hereof
  4. Development of impaired glucose tolerance and insulin resistance

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135460

Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, 2650
Department of Infectious Diseases, Aalborg Hospital
Aalborg, Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, Denmark, 8200
Department of Infectious Diseases, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Infectious Diseases, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Danish HIV Research Group
Rigshospitalet, Denmark
Hvidovre University Hospital
Odense University Hospital
Aarhus University Hospital
Aalborg Universitetshospital
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 Universitetshospital
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
More Information

ClinicalTrials.gov Identifier: NCT00135460     History of Changes
Other Study ID Numbers: 2612-2198
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: March 14, 2006
Last Verified: September 2005

Keywords provided by Danish HIV Research Group:
Treatment Naive
HIV Infections

Additional relevant MeSH terms:
HIV-Associated Lipodystrophy Syndrome
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents