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

Danish HIV Research Group100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

HIV Associated Lipodystrophy Syndrome.HIV Hypercholesterolemia Lipoatrophy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (4)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, Denmark

Department of Infectious Diseases, Rigshospitalet

Copenhagen, Denmark

Department of Infectious Diseases, Hvidovre University Hospital

Hvidovre, Denmark

Department of Infectious diseases, Odense University Hospital

Odense, Denmark

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.