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The purpose of this study is to observe the effects of certain anti-HIV medications on mitochondrial activity and fat cell death. This study will enroll participants from another study, ACTG A5202, who are on treatment regimens that do not include zidovudine, stavudine, or other thymidine-containing anti-HIV medications.
The main objective of this study is to observe the effects of anti-HIV medication lacking thymidine on mitochondrial metabolism and adipocyte apoptosis (fat cell death). Changes in mitochondrial metabolism and increases in adipocyte apoptosis are associated with lipoatrophy. Lipoatrophy is a common condition characterized by loss of subcutaneous fat and can be caused by many anti-HIV medications. This study will examine the metabolic consequences of the use of thymidine analogue-sparing treatment regimens.
This study will evaluate HIV infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen. This regimen will include either tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), which are thymidine-sparing regimens. The changes in mitochondrial activity and fat cell death will be compared between participants taking thymidine-sparing regimens (TDF/FTC or ABC/3TC) and thymidine-containing regimens.
This study will last for 96 weeks, with two study visits occurring at entry and another visit at Week 96. During each visit, a dual energy x-ray absorptiometry (DEXA) scan and blood collection will occur, and a fat biopsy will be performed in the lower abdomen under local anesthetic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC/3TC | HIV-infected subjects were given Abacavir-Lamuvidine | ||
| TDF/FTC | HIV-infected patients were given tenofovir DF-emtricitabine |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Mitochondrial Activity | mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction. | Entry, Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Apoptosis | Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry | Entry, Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen
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| Name | Affiliation | Role |
|---|---|---|
| Grace McComsey, MD | Case School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case School of Medicine | Cleveland | Ohio | 44106 | United States |
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| Label | URL |
|---|---|
| Click here for more information on ACTG A5202 and ACTG 5224 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABC/3TC | HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) |
| FG001 | TDF/FTC | HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABC/3TC | HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) |
| BG001 | TDF/FTC | HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mitochondrial Activity | mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction. | Posted | Median | Inter-Quartile Range | copies/cell | Entry, Week 96 |
|
the adverse event data was collected over the duration of the study of 96 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABC/3TC | HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Limitations included small sample size and premature study discontinuation before week 96
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace McComsey | Case Western Reserve University | 216-844-2739 | mccomsey.grace@clevelandactu.org |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Blood collection
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
HIV infected subjects taking atazanavir-ritonavir with tenofovir DF-emtricitabine at baseline
| OG003 | ATV/r +ABC/3TC | HIV-infected subjects taking atazanavir-ritonavir with abacavir-lamivudine at baseline |
|
|
| Secondary | Change in Fat Apoptosis | Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry | Posted | Median | Inter-Quartile Range | g | Entry, Week 48 |
|
|
|
| 28 |
| 2 |
| 28 |
| 0 |
| 28 |
| EG001 | TDF/FTC | HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r) | 1 | 28 | 0 | 28 | 0 | 28 |
| Depression | Psychiatric disorders | Systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System 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 |