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

Danish HIV Research Group100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

HIV-Associated Lipodystrophy Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (5)

Department of Infectious Diseases, Hvidovre University Hospital

Hvidovre, Copenhagen, 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, Odense University Hospital

Odense, Denmark

Outcomes

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