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.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 100
- Locations
- 9
- Primary Endpoint
- Changes in peripheral fat mass, determined by DEXA-changes
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
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