Clinical trial
Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare…
NCT00192621 · Kirby Institute, Other · Completed
Key facts
| NCT number | NCT00192621 |
|---|---|
| Title | Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects |
| Official title | A 3 Arm, Prospective Study to Compare the Effect of 6 Weeks Exposure to the Combination of Lopinavir (LPVr)/Combivir® (AZT/3TC) Versus Lopinavir Alone or Combivir® Alone in HIV-negative Healthy Subjects on the Development of Abnormalities of Lipid and Glucose Metabolism |
| Lead sponsor | Kirby Institute, Other |
| Collaborators | St Vincent's Hospital, Sydney National Heart, Lung, and Blood Institute (NHLBI) NIH Garvan Institute of Medical Research Prince of Wales Hospital, Sydney |
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | HIV Infections, Dyslipidemias, Glucose Metabolism Disorders, Metabolic Diseases, Lipodystrophy, Cardiovascular Disease |
| Intervention type | Drug |
| Interventions | Combivir (zidovudine [AZT] / lamivudine [3TC]), Kaletra (lopinavir [LPVr]) |
| Enrollment | 50 |
| Start date | Nov 1, 2004 |
| Primary completion | Dec 1, 2006 |
| Completion | Dec 1, 2006 |
| First posted | Sep 19, 2005 |
| Last update posted | Apr 12, 2012 |
| Countries | Australia |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: