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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Danish HIV Research Group.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Rigshospitalet, Denmark

Hvidovre University Hospital

Odense University Hospital

Aarhus University Hospital

Aalborg Universitetshospital

Abbott

Information provided by:

Danish HIV Research Group

ClinicalTrials.gov Identifier:

NCT00135460

First received: August 25, 2005

Last updated: March 13, 2006

Last verified: September 2005

History of Changes

Purpose

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.

Condition	Intervention	Phase
HIV-Associated Lipodystrophy Syndrome	Drug: nucleoside analogue sparing HAART regimen	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Proteinase inhibitor

Genetic and Rare Diseases Information Center resources: Lipodystrophy Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Danish HIV Research Group:

Primary Outcome Measures:

Changes in peripheral fat mass, determined by DEXA-changes
Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
Change from baseline in fasting lipids and subsets hereof
Development of impaired glucose tolerance and insulin resistance

Secondary Outcome Measures:

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
Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96
Change in plasma lactate from baseline
Time to discontinuation of the randomized therapy and reasons for this
Incidence of genotypical and virological resistance
Development of osteopenia, judged by DEXA-scan
Compliance – proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96


Estimated Enrollment:	100
Study Start Date:	June 2003
Estimated Study Completion Date:	November 2007

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135460

Locations


Denmark
Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, 2650
Department of Infectious Diseases, Aalborg Hospital
Aalborg, Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, Denmark, 8200
Department of Infectious Diseases, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Infectious Diseases, Odense University Hospital
Odense, Denmark, 5000

Sponsors and Collaborators

Danish HIV Research Group

Rigshospitalet, Denmark

Hvidovre University Hospital

Odense University Hospital

Aarhus University Hospital

Aalborg Universitetshospital

Abbott

Investigators


Study Chair:	Jan Gerstoft, M.D., DMSc	Rigshospitalet, Denmark
Principal Investigator:	Niels Obel, M.D., DMSc	Odense University Hospital
Principal Investigator:	Court Pedersen, Professor	Odense University Hospital
Principal Investigator:	Lars Mathiesen, M.D.,DMSc	Hvidovre University Hospital
Principal Investigator:	Henrik Nielsen, M.D.,DMSc	Aalborg Universitetshospital
Principal Investigator:	Alex Laursen, M.D., DMSc	Aarhus University City
Principal Investigator:	Ann-Brit E Hansen, M.D.	Copenhagen University Hospital Rigshospitalet and Odense University Hospital

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00135460 History of Changes
Other Study ID Numbers:	2612-2198
Study First Received:	August 25, 2005
Last Updated:	March 13, 2006
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Danish HIV Research Group:


HIV Lipoatrophy Lipodystrophy	Treatment Naive HIV Infections Hypercholesterolemia

Additional relevant MeSH terms:


HIV-Associated Lipodystrophy Syndrome Lipodystrophy HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases	Skin Diseases, Metabolic Virus Diseases HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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