Current partner codePEPTIDESDE
NCT00192660·Phase 4·INTERVENTIONAL

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Status

Completed

Phase

Phase 4

Enrollment

80

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in composition of fat throughout the body (loss in some areas and accumulation in others), elevations in blood lipids and abnormalities in glucose metabolism. The resulting syndrome is known as "HIV associated lipodystrophy" or HIVLD. In HIV negative populations, such abnormalities in lipid and glucose metabolism are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to characterize the changes that occur in body composition and metabolism with antiretroviral treatment and compare them to changes in fat tissue structure and function and surrogate markers for cardiovascular disease.

Interventions

Treatment arms and agents.

DRUG

Lamivudine

DRUG

Stavudine

DRUG

Didanosine

DRUG

Zidovudine

DRUG

Tenofovir

DRUG

Abacavir

DRUG

Efavirenz (EFV)

DRUG

Nevirapine

DRUG

Indinavir

DRUG

Saquinavir

DRUG

Amprenavir

DRUG

Ritonavir

Timeline

From registration to results.

  1. First posted

    Sep 19, 2005

  2. Study start

    Feb 2003

  3. Primary completion

    Oct 2006

  4. Study completion

    Dec 2007

  5. Results posted

    Not reported

  6. Registry updated

    Apr 12, 2012

Outcomes

What the study measures.

Primary outcomes

To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy

Secondary outcomes

To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen

To examine changes in adipocyte function in HIV-infected volunteers both prior to and after initiation of treatment in order to determine changes arising directly as a result of therapy

To investigate changes in adipocyte function in pre-treated HIV-infected volunteers with and without established signs of HIVLD in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

Australia. Showing up to 24 locations stored in the fast local snapshot.

St. Vincent's Hospital

Sydney, New South Wales, Australia

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Enfuvirtide.

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Put the record in context.

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