Status:
COMPLETED
Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
St Vincent's Hospital, Sydney
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
HIV Infections
Dyslipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 abnorm...
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, w...
Eligibility Criteria
Inclusion
- Age \>18
- Be able to provide written consent to perform in the trial.
- HIV antibody negative and HIV DNA negative at time of entry to the study.
Exclusion
- Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
- History of type I or type II diabetes mellitus or previous treatment with antidiabetic medication.
- Prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
- Alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
- Prior use of any retinoid-containing compound within the previous six months.
- Abnormal coagulation.
- Previous allergic reaction or known allergy to local anaesthetic.
- Previous use of psychotropic medications.
- Concomitant use of medications, including those metabolised by CYP3A4 enzyme system, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
- Any grade-three laboratory abnormality recorded from screening bloods.
- Any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
- Gastrointestinal disorders, which may affect drug absorption.
- Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
- Pregnancy
- Evidence of acute or chronic active hepatitis B virus infection by serology performed at baseline.
- Evidence of hepatitis C infection by serology performed at baseline.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00192621
Start Date
November 1 2004
End Date
December 1 2006
Last Update
April 12 2012
Active Locations (1)
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1
St Vincents Hospital
Sydney, New South Wales, Australia, 2010