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Completed

NCT Number: NCT00139178

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

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.

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Key information

Conditions

HIV Associated Lipodystrophy Syndrome. Blood-Borne Infections Communicable Diseases Dyslipidemias Genital Diseases HIV HIV Infections HIV-Associated Lipodystrophy Syndrome Hypercholesterolemia Hyperlipidemias Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Lipoatrophy Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Different HAART regimens

Drug

Primary outcomes

  1. 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 outcomes

  1. Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.

  2. Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks.

  3. Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks.

  4. Incidence of adverse events.

  5. Incidence of clinical disease progression.

  6. Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24,48 and 96.

  7. Change in plasma lactate from baseline.

  8. Time to discontinuation of the allocated therapy and reasons for this.

  9. 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.

Sponsors and collaborators

Lead sponsor

Danish HIV Research Group

Other

Collaborators

  • Aarhus University Hospital
  • Hvidovre University Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Aug 31, 2005
Registry last updated
Sep 5, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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