Clinical trial NCT00139178: Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.
Official title: Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Associated Lipodystrophy Syndrome.
HIV
Hypercholesterolemia
Lipoatrophy
Lead sponsor: Danish HIV Research Group
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Rigshospitalet, Denmark
name: Hvidovre University Hospital
name: Aarhus University Hospital
First posted: 2005-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
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 outcomes:
measure: Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
measure: Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks.
measure: Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks.
measure: Incidence of adverse events.
measure: Incidence of clinical disease progression.
measure: Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24,48 and 96.
measure: Change in plasma lactate from baseline.
measure: Time to discontinuation of the allocated therapy and reasons for this.
measure: 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.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Infectious Diseases, Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Department of Infectious Diseases, Rigshospitalet
city: Hvidovre
country: Denmark
facility: Department of Infectious Diseases, Hvidovre University Hospital
city: Odense
country: Denmark
facility: Department of Infectious diseases, Odense University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jan Gerstoft, M.D., DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Ann-Brit E Hansen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Court Pedersen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Lars Mathiesen, M.D. DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Alex Laursen, D.M., DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Niels Obel
role: STUDY_CHAIR
References: