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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139178
• Other study ID #: 26122450
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2005
• Last updated: September 2, 2005
• Start date: March 2004
• Est. completion date: April 2007

Study information

• Verified date: August 2005
• Source: Danish HIV Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Associated Lipodystrophy Syndrome.
• HIV-Associated Lipodystrophy Syndrome
• Hypercholesterolemia
• Lipoatrophy
• Lipodystrophy

Intervention

Drug:
• Different HAART regimens

Locations

Country	Name	City	State
Denmark	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

Sponsors (5)

Lead Sponsor	Collaborator
Danish HIV Research Group	Aarhus University Hospital, Hvidovre University Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
Secondary	Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks.
Secondary	Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks.
Secondary	Incidence of adverse events.
Secondary	Incidence of clinical disease progression.
Secondary	Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24,48 and 96.
Secondary	Change in plasma lactate from baseline.
Secondary	Time to discontinuation of the allocated therapy and reasons for this.
Secondary	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.