Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
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| ClinicalTrials.gov Identifier: NCT00135460 |
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Recruitment Status : Unknown
Verified September 2005 by Danish HIV Research Group.
Recruitment status was: Active, not recruiting
First Posted : August 26, 2005
Last Update Posted : March 14, 2006
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV-Associated Lipodystrophy Syndrome | Drug: nucleoside analogue sparing HAART regimen | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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. |
| Study Start Date : | June 2003 |
| Study Completion Date : | November 2007 |
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135460
| 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 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00135460 History of Changes |
| Other Study ID Numbers: |
2612-2198 |
| First Posted: | August 26, 2005 Key Record Dates |
| Last Update Posted: | March 14, 2006 |
| Last Verified: | September 2005 |
Keywords provided by Danish HIV Research Group:
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HIV Lipoatrophy Lipodystrophy |
Treatment Naive HIV Infections Hypercholesterolemia |
Additional relevant MeSH terms:
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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 HIV Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |