Status:

UNKNOWN

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

Lead Sponsor:

Danish HIV Research Group

Collaborating Sponsors:

Rigshospitalet, Denmark

Hvidovre University Hospital

Conditions:

HIV-Associated Lipodystrophy Syndrome

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 al...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

June 1 2003

Trial Type :

INTERVENTIONAL

End Date :

November 1 2007

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00135460

Start Date

June 1 2003

End Date

November 1 2007

Last Update

March 14 2006

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Department of Infectious Diseases, Hvidovre University Hospital

Hvidovre, Copenhagen, Denmark, 2650

2

Department of Infectious Diseases, Aalborg Hospital

Aalborg, Denmark

3

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, Denmark, 8200

4

Department of Infectious Diseases, Rigshospitalet

Copenhagen, Denmark, 2100