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

NCT00135460 | Unknown Phase 4

• 1 other identifier: 2612-2198
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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. 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.

Conditions

HIV-Associated Lipodystrophy Syndrome

Keywords

HIV; Lipoatrophy; Lipodystrophy; Treatment Naive; HIV Infections; Hypercholesterolemia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

Interventions

nucleoside analogue sparing HAART regimen DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• 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).

Sponsors & Collaborators

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

Study Sites (5)

Department of Infectious Diseases, Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Department of Infectious Diseases, Aalborg Hospital

Aalborg, Denmark

Location

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Department of Infectious Diseases, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Infectious Diseases, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naive adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.

  PMID: 28399815 DERIVED

MeSH Terms

Conditions

HIV-Associated Lipodystrophy Syndrome; Lipodystrophy; HIV Infections; Hypercholesterolemia

Condition Hierarchy (Ancestors)

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

  STUDY CHAIR

• 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 University Hospital

  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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 26, 2005
• Study Start: June 1, 2003
• Study Completion: November 1, 2007
• Last Updated: March 14, 2006

Record last verified: 2005-09

Locations

DK (5)