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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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HIV-Associated Lipodystrophy Syndrome

Intervention / Treatment
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* Drug: nucleoside analogue sparing HAART regimen


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nucleoside analogue sparing HAART regimen|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Lipoatrophy, Lipodystrophy, Treatment Naive, HIV Infections, Hypercholesterolemia