NCT00192660

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

3.7 years

First QC Date

September 12, 2005

Last Update Submit

April 11, 2012

Conditions

HIV-Associated Lipodystrophy SyndromeCardiovascular Disease

Keywords

HIVMetabolic abnormalityLipodystrophyCardiovascular diseaseTreatment NaiveTreatment ExperiencedHIV Infections

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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

Interventions

LamivudineDRUG
StavudineDRUG
DidanosineDRUG
ZidovudineDRUG
TenofovirDRUG
AbacavirDRUG
Efavirenz (EFV)DRUG
NevirapineDRUG
IndinavirDRUG
SaquinavirDRUG
AmprenavirDRUG
RitonavirDRUG
NelfinavirDRUG
TipranavirDRUG
enfuvirtide (T20)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Related Links

MeSH Terms

Conditions

HIV-Associated Lipodystrophy SyndromeCardiovascular DiseasesLipodystrophyHIV Infections

Interventions

LamivudineStavudineDidanosineZidovudineTenofovirabacavirefavirenzNevirapineIndinavirSaquinaviramprenavirRitonavirNelfinavirtipranavirEnfuvirtide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidineInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingRibonucleosidesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePyridinesIsoquinolinesQuinolinesThiazolesSulfur CompoundsAzolesPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Study Officials

  • Andrew D Carr, MD

    St. Vincents Hospital Sydney Limited

    PRINCIPAL INVESTIGATOR

  • David A Cooper, MD

    The National Centre in HIV Epidemiology and Clinical Research, Sydney

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

February 1, 2003

Primary Completion

October 1, 2006

Study Completion

December 1, 2007

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

AU(1)