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To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and without KALETRA (LPV 400 mg/RTV 100mg) q12h
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Other | GSK706769 new vs. current formulation; GSK706769 alone vs. GSK706769 plus Kaletra |
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| Part 2 | Other | GSK706769 alone for 10 days; GSK706769 + Kaletra for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK706769 & KALETRA | Drug | GSK706769 alone and GSK706769 + Kaletra |
|
| Measure | Description | Time Frame |
|---|---|---|
| GSK706769 PK | Part 1: 4 days; Part 2; 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| GSK706769 safety parameters, including adverse events, clinical laboratory, ECG, and vital signs assessments. | Part 1: 4 days; Part 2; 25 days | |
| Plasma GSK706769 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg. |
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Inclusion Criteria:
Exclusion Criteria:
An average weekly intake of >14 drinks/week for men or >7 drinks/week for women.
Note: One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Note: "Study" or "investigational" drugs include GSK706769 or Kaletra
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Note: this does not include plasma donation.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
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| Label | URL |
|---|---|
| Results for study CRR110744 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C558899 | lopinavir-ritonavir drug combination |
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| Part 1: 4 days; Part 2; 25 days |
| Plasma metabolite GSK1996847 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg. | Part 1: 4 days; Part 2; 25 days |
| Metabolite GSK1996847 AUC(0-t) and Cmax following repeat dose administration of GSK706769 QD for 10 days and following coadministration with Kaletra (LPV 400mg/RTV 100mg) q12h for 14 days. | Part 1: 4 days; Part 2; 25 days |
| Plasma protein and mRNA expression levels of biomarkers before and after administration of GSK706769 QD for 5 days. | Part 1: 4 days; Part 2; 25 days |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |