Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

NCT00139178 | Completed Phase 4

• 1 other identifier: 26122450
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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. The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy. We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir). The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir. The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.

Conditions

HIV Associated Lipodystrophy Syndrome.; HIV; Hypercholesterolemia; Lipoatrophy

Outcome Measures

Primary Outcomes (1)

• Changes in peripheral fat mass, determined by DEXA-Changes Change from baseline in fasting lipids and subsets hereof. Development of impaired glucose tolerance and insulin resistance.

Secondary Outcomes (9)

• Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.

• 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.

Interventions

Different HAART regimens DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently treated with lamivudine, zidovudine and abacavir
• Viral load \< 200 copies/ml
• Ability to understand and provide written informed consent.

You may not qualify if:

• 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.
• Creatinine \> 200 mmol/l.
• ALT or AST \> 5 times upper normal value (200U/l).

Sponsors & Collaborators

• Danish HIV Research Group: lead
• Odense University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Hvidovre University Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (4)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Department of Infectious Diseases, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Infectious Diseases, Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Department of Infectious diseases, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

HIV-Associated Lipodystrophy Syndrome; Hypercholesterolemia; Lipodystrophy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hyperlipidemias; Dyslipidemias

Study Officials

• Jan Gerstoft, M.D., DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Ann-Brit E Hansen, M.D.

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Court Pedersen, Professor

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Lars Mathiesen, M.D. DMSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Alex Laursen, D.M., DMSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Niels Obel

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: August 31, 2005
• Study Start: March 1, 2004
• Study Completion: April 1, 2007
• Last Updated: September 5, 2005

Record last verified: 2005-08

Locations

DK (4)