Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

HIV-Associated Lipodystrophy Syndrome Clinical Trial

Official title:

Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00135460
• Other study ID #: 2612-2198
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 25, 2005
• Last updated: March 13, 2006
• Start date: June 2003
• Est. completion date: November 2007

Study information

• Verified date: September 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.

There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy.

The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen.

The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Antiretroviral naïve patients

• HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.

• Fulfilling the criteria for starting antiretroviral therapy.

• 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.

• Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz.

• Creatinine > 200 mmol/l.

• ALT or AST > 5 times upper normal value (200U/l).

Study Design

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

Related Conditions & MeSH terms

• HIV-Associated Lipodystrophy Syndrome
• Lipodystrophy

Intervention

Drug:
• nucleoside analogue sparing HAART regimen

Locations

Country	Name	City	State
Denmark	Department of Infectious Diseases, Aalborg Hospital	Aalborg
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	Copenhagen
Denmark	Department of Infectious Diseases, Odense University Hospital	Odense

Sponsors (7)

Lead Sponsor	Collaborator
Danish HIV Research Group	Aalborg Universitetshospital, Aarhus University Hospital, Abbott, 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
Primary	Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
Primary	Change from baseline in fasting lipids and subsets hereof
Primary	Development of impaired glucose tolerance and insulin resistance
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 randomized therapy and reasons for this
Secondary	Incidence of genotypical and virological resistance
Secondary	Development of osteopenia, judged by DEXA-scan
Secondary	Compliance – proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96