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 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.

We 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 DEXA-scanning

Condition	Intervention	Phase
HIV-Associated Lipodystrophy Syndrome HIV Hypercholesterolemia	Drug: nucleoside analogue sparing HAART regimen	Phase IV

Further Study Details: 

Primary Outcomes: Changes in peripheral fat mass, determined by DEXA-Changes Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.; Change from baseline in fasting lipids and subsets hereof; Development of impaired glucose tolerance and insulin resistance
Secondary Outcomes: 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 randomized 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.
Expected Total Enrollment:  100

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Antiretroviral naïve patients
• HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.
• Indication of initiating 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 clinical significant interaction with lopinavir, ritonavir or efavirenz.
• Creatinine > 200 mmol/l.
• ALT or AST > 5 times upper normal value (200U/l).

Please refer to this study by ClinicalTrials.gov identifier  NCT00135460

Ann-Brit E Hansen, M.D.      +45 3545 7726    ann-brit.eg.hansen@rh.hosp.dk
Jan Gerstoft, M.D., DMSc      +45 3545 7744    gerstoft@rh.dk

Denmark
      Department of Infectious Diseases, Aalborg Hospital, Aalborg,  Denmark; Recruiting
      Department of Infectious Diseases, aarhus University Hospital, Aarhus,  8200,  Denmark; Recruiting
Denmark, -
      Department of Infectious Diseases, Rigshospitalet, Copenhagen,  -,  2100,  Denmark; Recruiting
      Department of Infectious diseases, Odense University Hospital, Odense,  -,  5000,  Denmark; Recruiting
Denmark, Copenhagen
      Department of Infectious Diseases, Hvidovre University Hospital, Hvidovre,  Copenhagen,  2650,  Denmark; Recruiting

Study chairs or principal investigators

Jan Gerstoft, M.D., DMSc,  Study Chair,  Copenhagen University Hospital Rigshospitalet   
Niels Obel, M.D., DMSc,  Principal Investigator,  Odense University Hospital   
Court Pedersen, professor,  Principal Investigator,  Odense University Hospital   
Lars Mathiesen, D.M:,DMSc,  Principal Investigator,  Hvidovre University Hospital   
Henrik Nielsen, M.D.,DMSc,  Principal Investigator,  Aalborg Hospital   
Alex Laursen, M.D., DMSc,  Principal Investigator,  Aarhus University City   
Ann-Brit E Hansen, M.D.,  Principal Investigator,  Copenhagen University Hospital Rigshospitalet and Odense University Hospital   

Study ID Numbers:  2612-2198
Last Updated:  August 25, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00135460
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-30