None listed
Conditions
Brief summary
1. To investigate the effect of HIV infection and treatment with highly active antiretroviral therapy on individual steps of reverse cholesterol transport and vascular function. 2. To investigate the effect of HIV infection and anti-HIV drugs on intracellular cholesterol metabolism.
Interventions
To compare untreated HIV-infected patients (patients who will not require therapy for the entire study duration of 12 months) with:
HIV-infected patients that are PI naïve and initiating therapy with a protease inhibitor containing HAART regime (ARV naïve or NNRTI experienced changing to PI regimen) at study baseline
and:
HIV-infected patients naïve to ARV therapy and initiating NNRTI-containing regimen at baseline of the study.
The participants will remain in the study for a durtation of 12
To compare untreated HIV-infected patients (patients who will not require therapy for the entire study duration of 12 months) with: HIV-infected patients that are PI naïve and initiating therapy with a protease inhibitor containing HAART regime (ARV naïve or NNRTI experienced changing to PI regimen) at study baseline and: HIV-infected patients naïve to ARV therapy and initiating NNRTI-containing regimen at baseline of the study. The participants will remain in the study for a durtation of 12 months on the same medication as at baseline. This study will not influence the therapeutic management of the participants. Patients who have to change therapy during the study with be withdrawn.
Sponsors
National Health and Medical Research Council of Australia (grants # 317811 and 317810(DS)
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Male patients with HIV infection. 3 groups of 50 patients each. HIV infected patients, naive to ARV therapy and not likely to need to commence therapy for the duration of follow-up (12 months). HIV-infected patients, PI naive, initiating therapy with PI-containing HAART (ARV naïve or NNRTI experienced changing to PI regimen). HIV-infected patients naive to ARV therapy, initiating NNRTI-containing regimen.
Exclusion criteria
Treatment with any form of lipid lowering drugs, including fish oils. Body Mass Index greater than 27.
Outcome results
None listed