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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL065953-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| St Vincent's Hospital, Sydney | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine | Drug | |||
| Stavudine | Drug | |||
| Didanosine | Drug | |||
| Zidovudine | Drug | |||
| Tenofovir | Drug | |||
| Abacavir | Drug | |||
| Efavirenz (EFV) | Drug | |||
| Nevirapine |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Specific to HIV Infection and Metabolic Abnormalities Protocol 1 (HAMA) part A only:
Specific to HAMA part B only:
Exclusion Criteria:
Specific to HAMA part A only:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Carr, MD | St. Vincents Hospital Sydney Limited | Principal Investigator |
| David A Cooper, MD | The National Centre in HIV Epidemiology and Clinical Research, Sydney | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Sydney | New South Wales | 2010 | Australia |
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| Label | URL |
|---|---|
| National Centre in HIV Epidemiology and Clinical Research Homepage | View source |
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| Drug |
| Indinavir | Drug |
| Saquinavir | Drug |
| Amprenavir | Drug |
| Ritonavir | Drug |
| Nelfinavir | Drug |
| Tipranavir | Drug |
| enfuvirtide (T20) | Drug |
| 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 |
| ID | Term |
|---|---|
| D039682 | HIV-Associated Lipodystrophy Syndrome |
| D002318 | Cardiovascular Diseases |
| D008060 | Lipodystrophy |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| D018119 | Stavudine |
| D016049 | Didanosine |
| D015215 | Zidovudine |
| D000068698 | Tenofovir |
| C106538 | abacavir |
| C098320 | efavirenz |
| D019829 | Nevirapine |
| D019469 | Indinavir |
| D019258 | Saquinavir |
| C095108 | amprenavir |
| D019438 | Ritonavir |
| D019888 | Nelfinavir |
| C107201 | tipranavir |
| D000077560 | Enfuvirtide |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012263 | Ribonucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011725 | Pyridines |
| D007546 | Isoquinolines |
| D011804 | Quinolines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
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