NCT00865475

Brief Summary

The aim of this study is to measure the prevention of lipoatrophy in patients treated with Lopinavir/R in monotherapy versus ZDV + 3TC + ABC

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

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

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

4.2 years

First QC Date

March 18, 2009

Last Update Submit

September 11, 2013

Conditions

HIV InfectionHIV Infections

Keywords

HIV infectionTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Limb Fat changes measured by DEXA

    48 weeks

Secondary Outcomes (3)

  • 20 % loss peripheral fat measured by DEXA

    96 weeks

  • Perception of change on body fat by physician and patient.

    96 weeks

  • Lipohypertrophy

    96 weeks

Study Arms (2)

TZV (Trizivir)

NO INTERVENTION

Keeping on TZV in patients with viral suppression

2

EXPERIMENTAL

Switching to LPV/r monotherapy

Drug: AZT+3TC+ABV (Trizivir)Drug: Switching to LPV/r monotherapy (Kaletra)

Interventions

AZT+3TC+ABV (Trizivir)DRUG

Patients on treatment with TZV and viral suppression will be randomized to keep on TZV vs switching to LPV/r monotherapy

Also known as: LPV/r (Kaletra)
2
Switching to LPV/r monotherapy (Kaletra)DRUG

Patients on AZT+3TC+ABV with viral suppression will be randomized to keep on vs switching to LPV/r

Also known as: Kaletra
2

Eligibility Criteria

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

You may qualify if:

  • Patients infected with HIV 1 documented by positive HIV 1 antibody test and/or positive PCR test confirmed for HIV 1 RNA.
  • Patients on treatment with Trizivir with an undetectable viral burden defined as \< 50 copies/ml in the past 6 months.
  • Men or women aged ≥ 18 years.
  • CD4 cell count ≥ 200 cells/μl.
  • For women of child bearing age, a negative urine pregnancy test at the screening visit.
  • Patients giving their written informed consent before completing any study specific screening procedure.

You may not qualify if:

  • Patients with previously failed therapy with protease inhibitors (PI) or those receiving sub optimum therapy with nucleoside analogue reverse transcriptase inhibitors (NRTI) for the study disease.
  • Presence of lipoatrophy defined by the investigator (any grade) or by the patient (in this case, at least two sites of mild degree or one of at least moderate degree).
  • Known history of drug addiction or chronic use of alcohol that, in the investigator's opinion, contraindicates participation in the study.
  • Pregnant or nursing women or women of child bearing age not using an adequate contraceptive method according to the investigator's criterion.
  • Current active opportunistic infection or documented infection in the 4 weeks prior to screening.
  • Renal disease with creatinine clearance \< 50 ml/min.
  • Concomitant use of nephrotoxic or immunosuppressive agents.
  • Patient currently treated with systemic corticosteroids, interleukine 2, or chemotherapy.
  • Patients treated with other investigational agents.
  • Patients with acute hepatitis.
  • Any disease that, at the criterion in the investigator, contraindicates the patient's participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Ntra.Sra. de Zumarraga

Zumarraga, Guipuzcua, 28700, Spain

Location

Hospital Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Doce de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, San Sebastian, 20014, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

H. Son Dureta

Mallorca, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir, lamivudine, and zidovudine drug combinationlopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jose Antonio Iribarren

    Hospital de Donostia

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations

ES(7)