Status:
UNKNOWN
MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Abbott
Boehringer Ingelheim
Conditions:
HIV Infections
HIV-Associated Lipodystrophy Syndrome
Eligibility:
MALE
18-70 years
Phase:
PHASE4
Brief Summary
This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.
Detailed Description
This is a randomized prospective study into metabolic adverse events during initial antiretroviral therapy in HIV-1-infected men. The following regimens are compared: lopinavir-ritonavir + Combivir an...
Eligibility Criteria
Inclusion
- Male
- Age between 18 and 70 years.
- No prior use of antiretroviral therapy
- Indication for antiretroviral treatment according to common standards
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00122226
Start Date
January 1 2003
End Date
July 1 2008
Last Update
April 25 2006
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Helsinki University Central Hospital
Helsinki, Finland
2
Academic Medical Center
Amsterdam, Netherlands
3
Medisch Centrum Jan van Goyen
Amsterdam, Netherlands
4
Onze Lieve Vrouwe Gasthuis, location Oosterpark
Amsterdam, Netherlands