HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001) (NCT00192660) | Clinical Trial Compass
CompletedPhase 4
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)
Australia80 participantsStarted 2003-02
Plain-language summary
This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (PI) containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18.
* Be able to provide written consent to perform in the trial.
* HIV antibody positive at time of entry to the study.
Specific to HIV Infection and Metabolic Abnormalities Protocol 1 (HAMA) part A only:
* Be naive to antiretroviral medication.
Specific to HAMA part B only:
* Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
* Have had a minimum of 48 weeks interval since completion of HAMA part A.
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.
* Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
* Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
* Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.
* Prior use of any retinoid-containing compound within the previous six months.
* Abnormal coagulation.
* Previous allergic reaction or known allergy to local anaesthetic.
* Previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy