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

• Status: Unknown status
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish HIV Research Group
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital; Aarhus University Hospital; Abbott; Hvidovre University Hospital; Odense University Hospital; Rigshospitalet, Denmark
• Treatments: HIV Protease Inhibitors; Protease Inhibitors

Criteria

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).