Trials / Completed
CompletedNCT00192621
Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Kirby Institute · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a randomised study of the effect of treatment with Combivir (zidovudine \[AZT\] and lamivudine \[3TC\]) and Kaletra (lopinavir \[LPVr\]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects.
Detailed description
Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in the way that fat is laid down on the body. This results in fat loss from some parts of the body, with fat deposits at other sites, giving a characteristic look known as "HIV associated lipodystrophy" or HIVLD. With these changes, there are also abnormalities in glucose and fat metabolism (collectively termed metabolic abnormalities). In HIV negative populations, these metabolic changes are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to investigate if changes in the body's handling of fats and glucose occur with a short course of treatment in HIV negative subjects and if these correlate to an increased risk of CVD.
Conditions
- HIV Infections
- Dyslipidemias
- Glucose Metabolism Disorders
- Metabolic Diseases
- Lipodystrophy
- Cardiovascular Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Combivir (zidovudine [AZT] / lamivudine [3TC]) | |
| DRUG | Kaletra (lopinavir [LPVr]) |
Timeline
- Start date
- 2004-11-01
- Primary completion
- 2006-12-01
- Completion
- 2006-12-01
- First posted
- 2005-09-19
- Last updated
- 2012-04-12
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT00192621. Inclusion in this directory is not an endorsement.