NCT00234975

Brief Summary

The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_4

Geographic Reach
1 country

11 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

October 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

5.3 years

First QC Date

September 13, 2005

Last Update Submit

January 2, 2013

Conditions

HIV Infection

Keywords

LopinavirRitonavirPhase 4HIV

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    Changes in liver functions enzyme.

    Baseline, Week 4, Week 8, Week 16 and Week 24

Secondary Outcomes (1)

  • Secondary Outcome Measures

    Baseline, Week 4, Week 8, Week 16 and Week 24

Study Arms (2)

HCV +

ACTIVE COMPARATOR
Drug: Lopinavir/Ritonavir

HCV -

ACTIVE COMPARATOR
Drug: Lopinavir/Ritonavir

Interventions

Lopinavir/RitonavirDRUG

400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator

Also known as: ABT-378, lopinavir/ritonavir, Kaletra
HCV +HCV -

Eligibility Criteria

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

You may qualify if:

  • Documented HIV positive.
  • At least 18 years of age.
  • Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
  • Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
  • Subject Has a Karnofsky Score greater than or equal to 70.
  • Subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in Kaletra concentration during concurrent administration.
  • The subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator.
  • Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin\> 8.0 g/dL; absolute neutrophil count \> 750 cells/mL; Platelet count \> 20,000/mL; ALT or AST \</=10 x upper limit of normal (ULN); Creatinine\< 1.5 x ULN; Triglycerides \</=750 mg/dL.
  • Subjects have no evidence of grade III or IV adverse event or laboratory abnormality (except for LFTs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Site Reference ID/Investigator# 4118

Bayamón, 00960, Puerto Rico

Location

Site Reference ID/Investigator# 4119

Bayamón, 00961, Puerto Rico

Location

Site Reference ID/Investigator# 6298

Juana Díaz, 00795, Puerto Rico

Location

Site Reference ID/Investigator# 6284

Las Piedras, 00771, Puerto Rico

Location

Site Reference ID/Investigator# 4101

Mayagüez, 00680, Puerto Rico

Location

Site Reference ID/Investigator# 4116

Playa de Ponce, 00731, Puerto Rico

Location

Site Reference ID/Investigator# 4117

Ponce, 00717-1563, Puerto Rico

Location

Site Reference ID/Investigator# 4099

Ponce, 00731, Puerto Rico

Location

Site Reference ID/Investigator# 4086

Rio Piedras, 00926, Puerto Rico

Location

Site Reference ID/Investigator# 4080

San Juan, 00908, Puerto Rico

Location

Site Reference ID/Investigator# 4100

Santurce, 00909, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

LopinavirRitonavirlopinavir-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

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Carlos R Rivera-Vazquez, MD

    AbbVie

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 10, 2005

Study Start

October 1, 2002

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations

PR(11)