Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- HIV Associated Lipodystrophy Syndrome.
- Sponsor
- Danish HIV Research Group
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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.
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.
Investigators
Eligibility 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).
Outcomes
Primary Outcomes
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
- 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.