NCT00389194

Brief Summary

The main objective of the study is to assess changes in fat distribution over 48 weeks of treatment in patients who currently successfully use zidovudine (AZT) and lamivudine (3TC) as part of their regimen and who will either continue these antiretrovirals or who will switch these antiretrovirals to tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Each of these medications is commonly used for the treatment of HIV-1 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

First QC Date

October 17, 2006

Last Update Submit

June 10, 2010

Conditions

HIV Infections

Keywords

HIV-1 infectionfat distributionlipodystrophylipidskidney functionTreatment Experienced

Outcome Measures

Secondary Outcomes (8)

  • Difference between the continuation arm and the switch arm in:

  • changes in subcutaneous and visceral abdominal fat by CT and truncal fat by whole body DEXA over 48 weeks

  • changes in lipids (total-, HDL-, and LDL-cholesterol, total /HDL cholesterol ratio, triglycerides), and glucose-metabolism (glucose, insulin) and insulin resistance (HOMA-index1) over 48 weeks.

  • incidence of new onset of lipodystrophy and changes in lipodystrophy severity according to the LDCD score.

  • changes in bone mineral density by regional DEXA (vertebra L4 and femoral neck) over 48 weeks

  • +3 more secondary outcomes

Interventions

continuing AZT+3TC or switching AZT+3TC to TDF+ FTCDRUG

Eligibility Criteria

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

You may qualify if:

  • Providing written informed consent
  • HIV-1 infected patients.
  • At least 18 years of age.
  • Males or non-pregnant, non-lactating females. Women of childbearing age must have a negative urine pregnancy test at screening. All female participants must be encouraged to utilise adequate contraception for the month preceding entry and for the duration of the study.
  • Treatment for at least two years with a first-line regimen of zidovudine plus lamivudine (as either a fixed dose combination or dosed separately) plus either an NNRTI or a (boosted) PI. Patients may have previously used multiple drugs from both the NNRTI or the PI classes.
  • Plasma HIV-1 RNA levels \< 50 copies/mL for at least 6 months at screening. Isolated measurements of plasma HIV-1 RNA levels above 50 but below 200 copies/ml (socalled blips) are allowed.

You may not qualify if:

  • Prior treatment with an NRTI other than zidovudine or lamivudine.
  • Use of a triple NRTI antiretroviral regimen or a regimen including unboosted saquinavir, fusion inhibitors or hydroxyurea
  • Prior virological treatment failure, defined as having had to switch antiretroviral therapy because of virologic failure in the opinion of the physician.
  • HIV-2 co-infection.
  • Renal impairment and/or use of nephrotoxic agents which in the opinion of the investigator are a contraindication for the use of tenofovir disoproxil fumarate.
  • Clinically relevant laboratory abnormalities: anemia, thrombocytopenia, leucopenia, elevated liver transaminases, elevated bilirubin, elevated amylase, elevated lipase.
  • Use of co-medication, other than antiretroviral drugs, with a known pharmacological interaction with one or more of the study drugs
  • Active alcohol or drug use, sufficient in the investigator's opinion to prevent compliance with the dosing schedule and evaluations (methadone and buprenorphine use is allowed, although the dose of methadone might need to be adjusted).
  • Anticipated non-compliance with the protocol.
  • Presence of a newly (within 30 days prior to the time of enrolment) diagnosed HIV-related opportunistic infection or condition which may interfere with the ability to comply with the study.
  • Chronic active viral hepatitis or other chronic liver disease, which in the opinion of the investigator is a contraindication for the use of any of the study drugs.
  • Women who have the intention to become pregnant during the study period.
  • Patients who have received within 4 weeks prior to entry, or who have an anticipated need for treatment with radiation therapy or cytotoxic chemotherapeutic agents during the protocol study period.
  • Patients who have taken any investigational drug 30 days prior to the start of the study
  • Patients with malabsorption syndrome or other gastrointestinal dysfunction which may interfere with drug absorption or prevent the patient from taking oral medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Centre

Amsterdam, Netherlands

Location

Related Publications (1)

  • Cotter AG, Vrouenraets SM, Brady JJ, Wit FW, Fux CA, Furrer H, Brinkman K, Sabin CA, Reiss P, Mallon PW; PREPARE (Preventing Progression of Adipose Tissue Redistribution) Investigators. Impact of switching from zidovudine to tenofovir disoproxil fumarate on bone mineral density and markers of bone metabolism in virologically suppressed HIV-1 infected patients; a substudy of the PREPARE study. J Clin Endocrinol Metab. 2013 Apr;98(4):1659-66. doi: 10.1210/jc.2012-3686. Epub 2013 Feb 22.

    PMID: 23436922DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsLipodystrophy

Condition Hierarchy (Ancestors)

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

Study Officials

  • Peter Reiss, MD, PhD

    Academic Medical Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

April 1, 2006

Study Completion

October 1, 2008

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

NL(1)