Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
Recruitment status was Active, not recruiting
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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. |
- 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
- 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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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).
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 |
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 Universityhospital |
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 |
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:
Lipodystrophy HIV-Associated Lipodystrophy Syndrome Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 03, 2013