Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.
This study has been completed.
Sponsor:
Danish HIV Research Group
Collaborators:
Odense University Hospital
Rigshospitalet, Denmark
Hvidovre University Hospital
Aarhus University Hospital
Information provided by:
Danish HIV Research Group
ClinicalTrials.gov Identifier:
NCT00139178
First received: August 30, 2005
Last updated: September 2, 2005
Last verified: August 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Associated Lipodystrophy Syndrome. HIV Hypercholesterolemia Lipoatrophy |
Drug: Different HAART regimens |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities |
Resource links provided by NLM:
Further study details as provided by Danish HIV Research Group:
Primary Outcome Measures:
- 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:
- 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 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 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | April 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Criteria
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).
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 Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139178
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139178
Locations
| Denmark | |
| Department of Infectious Diseases, Aarhus University Hospital | |
| Aarhus, Denmark, 8200 | |
| Department of Infectious Diseases, Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| Department of Infectious Diseases, Hvidovre University Hospital | |
| Hvidovre, Denmark, 2650 | |
| Department of Infectious diseases, Odense University Hospital | |
| Odense, Denmark, 5000 | |
Sponsors and Collaborators
Danish HIV Research Group
Odense University Hospital
Rigshospitalet, Denmark
Hvidovre University Hospital
Aarhus University Hospital
Investigators
| Principal Investigator: | Jan Gerstoft, M.D., DMSc | Rigshospitalet, Denmark | |
| Principal Investigator: | Ann-Brit E Hansen, M.D. | Odense University Hospital | |
| Principal Investigator: | Court Pedersen, Professor | 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00139178 History of Changes |
| Other Study ID Numbers: | 26122450 |
| Study First Received: | August 30, 2005 |
| Last Updated: | September 2, 2005 |
| Health Authority: | Denmark: Danish Medicines Agency |
Additional relevant MeSH terms:
|
HIV-Associated Lipodystrophy Syndrome Hypercholesterolemia Dyslipidemias HIV Infections Hyperlipidemias Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral |
Skin Diseases Skin Diseases, Metabolic Virus Diseases Lopinavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015