HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)
This study has been completed.
Sponsor:
Kirby Institute
Collaborators:
St Vincent's Hospital, Sydney
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00192660
First received: September 12, 2005
Last updated: April 11, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (PI) containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-Associated Lipodystrophy Syndrome Cardiovascular Disease |
Drug: Lamivudine Drug: Stavudine Drug: Didanosine Drug: Zidovudine Drug: Tenofovir Drug: Abacavir Drug: Efavirenz (EFV) Drug: Nevirapine Drug: Indinavir Drug: Saquinavir Drug: Amprenavir Drug: Ritonavir Drug: Nelfinavir Drug: Tipranavir Drug: enfuvirtide (T20) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time |
Resource links provided by NLM:
Further study details as provided by Kirby Institute:
Primary Outcome Measures:
- To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy
Secondary Outcome Measures:
- To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen
- To examine changes in adipocyte function in HIV-infected volunteers both prior to and after initiation of treatment in order to determine changes arising directly as a result of therapy
- To investigate changes in adipocyte function in pre-treated HIV-infected volunteers with and without established signs of HIVLD in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump
| Enrollment: | 80 |
| Study Start Date: | February 2003 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in composition of fat throughout the body (loss in some areas and accumulation in others), elevations in blood lipids and abnormalities in glucose metabolism. The resulting syndrome is known as "HIV associated lipodystrophy" or HIVLD. In HIV negative populations, such abnormalities in lipid and glucose metabolism are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to characterize the changes that occur in body composition and metabolism with antiretroviral treatment and compare them to changes in fat tissue structure and function and surrogate markers for cardiovascular disease.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age >18.
- Be able to provide written consent to perform in the trial.
- HIV antibody positive at time of entry to the study.
Specific to HIV Infection and Metabolic Abnormalities Protocol 1 (HAMA) part A only:
- Be naive to antiretroviral medication.
Specific to HAMA part B only:
- Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
- Have had a minimum of 48 weeks interval since completion of HAMA part A.
Exclusion Criteria:
- Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
- Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
- Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
- Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.
- Prior use of any retinoid-containing compound within the previous six months.
- Abnormal coagulation.
- Previous allergic reaction or known allergy to local anaesthetic.
- Previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
- Any grade-three laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
- Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
- Pregnancy
Specific to HAMA part A only:
- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors). Entry of individuals who have had previous antiretroviral therapy as part of post exposure prophylaxis will be at the discretion of the study investigators.
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: NCT00192660
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192660
Locations
| Australia, New South Wales | |
| St. Vincent's Hospital | |
| Sydney, New South Wales, Australia, 2010 | |
Sponsors and Collaborators
Kirby Institute
St Vincent's Hospital, Sydney
Investigators
| Principal Investigator: | Andrew D Carr, MD | St. Vincents Hospital Sydney Limited | |
| Study Director: | David A Cooper, MD | The National Centre in HIV Epidemiology and Clinical Research, Sydney |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kirby Institute |
| ClinicalTrials.gov Identifier: | NCT00192660 History of Changes |
| Other Study ID Numbers: | HAMA 001 Version 6, RO1 HL65953-01 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 11, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Kirby Institute:
|
HIV Metabolic abnormality Lipodystrophy Cardiovascular disease |
Treatment Naive Treatment Experienced HIV Infections |
Additional relevant MeSH terms:
|
Cardiovascular Diseases 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 |
ClinicalTrials.gov processed this record on February 27, 2015