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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00192621




Registration number
NCT00192621
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
12/04/2012

Titles & IDs
Public title
Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
ACTR012605000661673
Secondary ID [2] 0 0
SAMA 002 Version 5
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Dyslipidemias 0 0
Glucose Metabolism Disorders 0 0
Metabolic Diseases 0 0
Lipodystrophy 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Combivir (zidovudine [AZT] / lamivudine [3TC])
Treatment: Drugs - Kaletra (lopinavir [LPVr])

Treatment: Drugs: Combivir (zidovudine [AZT] / lamivudine [3TC])


Treatment: Drugs: Kaletra (lopinavir [LPVr])
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine effect of 6 wks ART with LPVr and CBV, alone and in combination, in HIV negative healthy subjects with respect to changes from baseline in genes related to mitochondrial and lipid metabolism in adipocytes
Timepoint [1] 0 0
Secondary outcome [1] 0 0
includes: To determine the effect of 6 wks of ART with LPVr and CBV in HIV negative subjects with respect to: changes from baseline in genes related to mitochondrial and lipid and glucose metabolism in monocytes.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincents Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital, Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Garvan Institute of Medical Research
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Prince of Wales Hospital, Sydney
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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 abnormalities in lipid and glucose metabolism in HIV negative healthy
subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00192621
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew D Carr, MD
Address 0 0
National Centre in HIV Epidemiology and Clinical Research.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00192621