NCT00247143

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of higher doses of lopinavir/ritonavir, in combination with other anti-HIV medications when administered as either the capsule or liquid formulations, among patients who have not had full viral suppression despite treatment with 3 classes of HIV medications, and at least 2 prior courses of treatment with HIV protease inhibitors. In addition, pharmacokinetics of the active agents, lopinavir and ritonavir will be measured following administration of both the liquid and capsule formulations and compared.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
Last Updated

September 20, 2006

Status Verified

September 1, 2006

First QC Date

October 28, 2005

Last Update Submit

September 18, 2006

Conditions

HIVAIDS

Keywords

Protease InhibitorAntiretroviral AgentsTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and efficacy of high dose kaletra liquid and capsules in the treatment of highly antiretroviral experienced, protease inhibitor resistant HIV disease.

Secondary Outcomes (1)

  • To compare traditional pharmacokinetic measures of the two formulations (kaletra liquid and kaletra capsules) in a subset of the patients included in the primary analysis.

Interventions

Kaletra (drug)DRUG

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent prior to trial participation.
  • HIV-1 infected males or females at least 18 years of age.
  • Weight \> 60 kg and \< 100 kg

You may not qualify if:

  • Three class ARV experienced, including current PI regimen for at least 12 weeks, at least one other PI based regimen for at least 12 weeks, treatment with at least one NNRTI and with at least 2 nucleoside agents.
  • Screening Virologic Phenotype demonstrating lopinavir phenotypic fold resistance between 10 and 80 (if patients have had Virologic Phenotype within 8 weeks of study screening this may be used as the qualifying lopinavir phenotypic fold resistance).
  • HIV-1 viral load 1000 copies/mL at screening.
  • Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
  • Total Cholesterol ≤ DAIDS Grade 3
  • Total Triglycerides ≤ DAIDS Grade 3
  • ALT and AST ≤DAIDS Grade 3).
  • Any Grade GGT is acceptable.
  • Any Grade CK is acceptable as long as there is no concurrent myopathy.
  • All other laboratory test values ≤DAIDS Grade 2.
  • Willingness to discontinue treatment with NNRTIs throughout 48 weeks of study participation (prior or current treatment with enfuvirtide is permitted).
  • Acceptable medical history, as assessed by the investigator, with an unremarkable chest X-ray and ECG within 1 year of study participation.
  • Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system (these are listed in the informed consent under the risks of lopinavir/ritonavir).
  • A prior AIDS-defining event is acceptable as long as it has resolved or the patient has been on stable therapy for at least 12 weeks.
  • ARV medication naïve.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

lopinavir-ritonavir drug combinationPharmaceutical Preparations

Condition Hierarchy (Ancestors)

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

Study Officials

  • Harry W. Lampiris, M.D.

    San Francisco Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry W. Lampiris, M.D.

CONTACT

415-379-5608harry.lampiris@med.va.gov

Sandra Charles, R.N.

CONTACT

415-221-4810sandra.charles@med.va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

October 28, 2005

First Posted

November 1, 2005

Study Start

October 1, 2005

Last Updated

September 20, 2006

Record last verified: 2006-09

Locations

US(1)