MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

• Status: Unknown status
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.

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

Details

• Lead Sponsor: VU University Medical Center
• Collaborators: Abbott; Boehringer Ingelheim
• Treatments: Lamivudine; Lopinavir; Nevirapine; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

• Male

• Age between 18 and 70 years.

• No prior use of antiretroviral therapy

• Indication for antiretroviral treatment according to common standards

Exclusion Criteria:

• Female sex

• Body mass index (kg/m2) > 35.

• Known history of diabetes mellitus or hyperlipidemia

• Use of coenzyme A reductase inhibitor or fibric acid derivative in the last 6 weeks before inclusion

• Use of the following medication: systemic corticosteroids, thiazide diuretics, calcium-entry blockers, angiotensin-converting inhibitors, nitrates

• Use of nandrolone or testosterone

• Any disorder or condition which can be expected to lead to lessened compliance with the study protocol.