NCT00148759

Brief Summary

The levels of lopinavir achieved in the blood following oral ingestion of standard doses of Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in HIV-infected women receiving the same dose of the drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_4 hiv-infections

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

October 22, 2013

Completed
Last Updated

December 3, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

September 6, 2005

Results QC Date

November 24, 2009

Last Update Submit

November 8, 2013

Conditions

HIV Infections

Keywords

Sex differencesPharmacokineticLopinavir/ritonavirTreatment ExperiencedHIV-infection

Outcome Measures

Primary Outcomes (1)

  • 24-hr LPV AUC

    Steady state(2 weeks after therapy change)

    24 hours

Secondary Outcomes (1)

  • 24-hr LPV Cmax

    24 hours

Study Arms (2)

adult male subjects

ACTIVE COMPARATOR

LPV/r 800/200 mg once daily

Drug: LPV/r

Adult female subjects

EXPERIMENTAL

LPV/r 800/200 mg once daily

Drug: LPV/r

Interventions

LPV/rDRUG

LPV/r 800/200 mg once daily

Also known as: Daily LPV/r, Kaletra
Adult female subjectsadult male subjects

Eligibility Criteria

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

You may qualify if:

  • Age greater or equal to 18 years
  • Diagnosis of HIV infection as previously established by HIV Enzyme-Linked Immunosorbent Assay (ELISA) test and confirmed by Western blot analysis.
  • Must have been taking LPV/r as part of an antiretroviral regimen at a dose of 400/100 mg orally twice per day for at least 3 months.
  • Recent (within last 90 days) HIV-RNA copies must be less than 400 copies/ml

You may not qualify if:

  • Hepatic abnormality: alanine-aminotransferase (ALT), aspartate-aminotransferase (AST) or total bilirubin (TBR) ≥ 3 x upper limit of normal
  • Renal insufficiency: serum creatinine ≥ 2 mg/dl
  • Co-infection with hepatitis B and/or C viruses
  • Pregnant or breastfeeding
  • Use of concurrent medications known to affect lopinavir or ritonavir concentrations significantly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Infectious Diseases Program

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

  • Ofotokun I, Chuck SK, Binongo JN, Palau M, Lennox JL, Acosta EP. Lopinavir/Ritonavir pharmacokinetic profile: impact of sex and other covariates following a change from twice-daily to once-daily therapy. J Clin Pharmacol. 2007 Aug;47(8):970-7. doi: 10.1177/0091270007302564. Epub 2007 Jul 5.

    PMID: 17615254RESULT

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

lopinavir-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 DiseasesSlow Virus Diseases

Results Point of Contact

Title
Ighovwerha Ofotokun, MD, MSc
Organization
Emory University
iofotok@emory.edu
404-616-0659

Study Officials

  • Igho Ofotokun, MD, MSc

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

June 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

December 3, 2013

Results First Posted

October 22, 2013

Record last verified: 2013-11

Locations

US(1)