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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI064029 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| University of Hawaii | OTHER |
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This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection. Additionally, markers of side effects were correlated with blood levels of the drugs. The hypothesis was that women and those with HIV would have higher drug levels, as well as markers of side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-negative | Active Comparator | This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women. |
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| HIV-infected | Active Comparator | This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zidovudine 300mg and lamivudine 150mg as Combivir | Drug | twice daily for 12 days in the HIV-negative group and indefinitely for their care in the HIV-positive group |
|
| Measure | Description | Time Frame |
|---|---|---|
| ZDV-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject | To compare ZDV- triphosphate concentrations in HIV-negative versus HIV-infected subjects. | Day 12 of dosing |
| 3TC-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject | To compare 3TC- triphosphate concentrations in HIV-negative versus HIV-infected subjects. | Day 12 of dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter L. Anderson, PharmD | University of Colorado Denver and Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver and Health Sciences Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19372976 | Background | Anderson PL. Recent developments in the clinical pharmacology of anti-HIV nucleoside analogs. Curr Opin HIV AIDS. 2008 May;3(3):258-65. doi: 10.1097/COH.0b013e3282f85dc1. | |
| 20953318 | Background | Anderson PL, Rower JE. Zidovudine and Lamivudine for HIV Infection. Clin Med Rev Ther. 2010;2:a2004. | |
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No plan to share.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV-negative | This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women. zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group |
| FG001 | HIV-infected | This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group. zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV-negative | This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women. zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group |
| BG001 | HIV-infected |
| 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 | ZDV-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject | To compare ZDV- triphosphate concentrations in HIV-negative versus HIV-infected subjects. | Posted | Median | Inter-Quartile Range | pmol/10^6 cells | Day 12 of dosing |
|
Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
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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 | HIV-negative | This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women. zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal lab- Bilirubin | Hepatobiliary disorders | Systematic Assessment | bilirubin increase |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Anderson | University of Colorado | Skaggs School of Pharmacy and Pharmaceutical Sciences | 3037246128 | peter.anderson@cuanschutz.edu |
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| ID | Term |
|---|---|
| D015215 | Zidovudine |
| D019259 | Lamivudine |
| C109078 | lamivudine, zidovudine drug combination |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 22960662 |
| Background |
| Ghodke Y, Anderson PL, Sangkuhl K, Lamba J, Altman RB, Klein TE. PharmGKB summary: zidovudine pathway. Pharmacogenet Genomics. 2012 Dec;22(12):891-4. doi: 10.1097/FPC.0b013e32835879a8. No abstract available. |
| 21465499 | Result | Rower JE, Klein B, Bushman LR, Anderson PL. Validation of a sensitive LC/MS/MS method for the determination of zidovudine and lamivudine in human plasma. Biomed Chromatogr. 2012 Jan;26(1):12-20. doi: 10.1002/bmc.1617. Epub 2011 Apr 4. |
| 17721092 | Result | Anderson PL, Zheng JH, King T, Bushman LR, Predhomme J, Meditz A, Gerber J, Fletcher CV. Concentrations of zidovudine- and lamivudine-triphosphate according to cell type in HIV-seronegative adults. AIDS. 2007 Sep 12;21(14):1849-54. doi: 10.1097/QAD.0b013e3282741feb. |
| 22391541 | Result | Rower JE, Meditz A, Gardner EM, Lichtenstein K, Predhomme J, Bushman LR, Klein B, Zheng JH, Mawhinney S, Anderson PL. Effect of HIV-1 infection and sex on the cellular pharmacology of the antiretroviral drugs zidovudine and lamivudine. Antimicrob Agents Chemother. 2012 Jun;56(6):3011-9. doi: 10.1128/AAC.06337-11. Epub 2012 Mar 5. |
This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group. zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | 3TC-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject | To compare 3TC- triphosphate concentrations in HIV-negative versus HIV-infected subjects. | Posted | Median | Inter-Quartile Range | pmol/10^6 cells | Day 12 of dosing |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 7 |
| 20 |
| EG001 | HIV-infected | This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group. zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group | 0 | 23 | 0 | 23 | 8 | 23 |
|
| Abnormal Lab- albumin | Hepatobiliary disorders | Systematic Assessment | Decrease in albumin |
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| Abnormal Lab- Alanine Aminotransferase (ALT) | Hepatobiliary disorders | Systematic Assessment | increase in Alanine Aminotransferase (ALT) |
|
| Abnormal Lab- Aspartate transaminase (AST) | Hepatobiliary disorders | Systematic Assessment | increase in Aspartate transaminase (AST) |
|
| Abnormal Lab- Amylase | Endocrine disorders | Systematic Assessment | Increase in amylase |
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| Nausea, Vomiting, and/or Diarrhea | Gastrointestinal disorders | Systematic Assessment | GI distress leading to subject withdrawal |
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| D006571 |
| Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |