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Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects

NCT00192621 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-04-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Combivir (zidovudine [AZT] / lamivudine [3TC])

DRUG

Kaletra (lopinavir [LPVr])

Sponsors & Collaborators

  • St Vincent's Hospital, Sydney

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Garvan Institute of Medical Research

    collaborator OTHER

  • Prince of Wales Hospital, Sydney

    collaborator OTHER_GOV

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Andrew D Carr, MD · National Centre in HIV Epidemiology and Clinical Research.

  • David A Cooper, MD · National Centre in HIV Epidemiology and Clinical Research.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00192621 on ClinicalTrials.gov