RecruitingPhase 4ACTRN12605000661673

Seronegatives And Metabolic Abnormalities Protocol 2 (SAMA 002)

A three arm, prospective study to compare the effect of six 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.


Sponsor

The University of New South Wales

Enrollment

50 participants

Start Date

Nov 1, 2004

Study Type

Interventional

Conditions

Summary

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how common HIV medicines — specifically Combivir (a combination of two antiretroviral drugs) and Kaletra (a protease inhibitor) — affect cholesterol, blood fats, and blood sugar levels in healthy people who do not have HIV. Understanding these metabolic effects in HIV-negative volunteers helps researchers separate the drug effects from the effects of HIV infection itself. You may be eligible if: - You are 18 years or older - You have tested negative for HIV (both antibody and DNA tests) - You are able to give written consent to take part You may NOT be eligible if: - You have any ongoing physical or mental health condition that would affect your ability to participate (including suspected heart disease) - You have a history of type 1 or type 2 diabetes, or have previously taken diabetes medication - You have used testosterone, oestrogen, growth hormone, oral steroids, or anabolic steroids in the past 6 months - You have a history of alcohol or drug abuse - You have previously used any antiretroviral medicines (including HIV post-exposure treatment) - You have used retinoid-containing compounds in the past 6 months - You are pregnant - You have hepatitis B or hepatitis C infection - You have abnormal blood test results from screening Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

A three arm, prospective study to compare the effect of six weeks exposure to the combination of lopinavir (LPVr)/Combivir (AZT/3TC) versus lopinavir alone or Combivir alone in HIV-negative healthy su

A three arm, prospective study to compare the effect of six 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.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12605000661673


Related Trials