Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities

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.

The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy.

We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir).

The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir.

The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.

Study Overview

• Status: Completed
• Conditions: HIV; Hypercholesterolemia; Lipoatrophy; HIV Associated Lipodystrophy Syndrome.
• Intervention / Treatment: Drug: Different HAART regimens

• Study Type: Interventional
• Enrollment: 100
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Currently treated with lamivudine, zidovudine and abacavir
• Viral load < 200 copies/ml
• 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.
• Creatinine > 200 mmol/l.
• ALT or AST > 5 times upper normal value (200U/l).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-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 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.
Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
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 allocated 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

• Sponsor: Danish HIV Research Group
• Collaborators: Odense University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; Hvidovre University Hospital
• Investigators: Principal Investigator: Court Pedersen, Professor, Odense University Hospital; Principal Investigator: Jan Gerstoft, M.D., DMSc, Rigshospitalet, Denmark; Principal Investigator: Ann-Brit E Hansen, M.D., Odense University Hospital; Principal Investigator: Lars Mathiesen, M.D. DMSc, Hvidovre University Hospital; Principal Investigator: Alex Laursen, D.M., DMSc, Aarhus University Hospital; Study Chair: Niels Obel, Odense University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Study Completion: April 1, 2007

Study Registration Dates

• First Submitted: August 30, 2005
• First Submitted That Met QC Criteria: August 30, 2005
• First Posted (Estimate): August 31, 2005

Study Record Updates

• Last Update Posted (Estimate): September 5, 2005
• Last Update Submitted That Met QC Criteria: September 2, 2005
• Last Verified: August 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; HIV Infections; Skin Diseases, Metabolic; Hypercholesterolemia; Lipodystrophy; HIV-Associated Lipodystrophy Syndrome
• Other Study ID Numbers: 26122450