HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kirby Institute
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); St Vincent's Hospital, Sydney
• Treatments: Abacavir; Amprenavir; Didanosine; Efavirenz; Enfuvirtide; Indinavir; Lamivudine; Nelfinavir; Nevirapine; Ritonavir; Saquinavir; Stavudine; Tenofovir; Tipranavir; Zidovudine

Criteria

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.

• Any grade-three 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.

• 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

Specific to HAMA part A only:

• Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors). Entry of individuals who have had previous antiretroviral therapy as part of post exposure prophylaxis will be at the discretion of the study investigators.