NCT00046033

Brief Summary

The purpose of this study is to see if adjusting the dose of lopinavir/ritonavir (LPV/r) has a better effect on lowering HIV viral load (the amount of HIV in the blood) compared to taking the standard FDA-approved LPV/r dose. This study will also compare the safety and tolerability of these two types of dosing.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Geographic Reach
1 country

6 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

First Submitted

Initial submission to the registry

September 18, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Last Updated

March 1, 2011

Status Verified

May 1, 2005

First QC Date

September 18, 2002

Last Update Submit

February 28, 2011

Conditions

HIV Infections

Keywords

Dose-Relationship, DrugHIV Protease InhibitorsSalvage TherapyViral LoadRNA, ViralDrug Therapy, Combination

Interventions

Lopinavir/ritonavirDRUG
RitonavirDRUG
SaquinavirDRUG
Tenofovir disoproxil fumarateDRUG
AmprenavirDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infection
  • Viral load \>= 5000 copies/ml within 45 days prior to study entry
  • Documented reduction in LPV sensitivity based on results obtained within 45 days prior to study entry
  • Prior experience with 2 or more NRTIs for at least 6 months each
  • At least 12 weeks of stable antiretroviral treatment that includes at least one PI prior to study entry and may include TDF and/or T-20 for 8 weeks or more immediately prior to study entry
  • Negative pregnancy test within 14 days prior to study entry
  • Agree not to become pregnant or to impregnate and to use an acceptable form of contraception while receiving study drugs and for 4 weeks after stopping study drugs

You may not qualify if:

  • Pregnant or breast-feeding.
  • Certain drugs within 14 days prior to study entry
  • Nonnucleoside reverse transcriptase inhibitors (NNRTIs) within 14 days prior to study entry
  • History of intolerance to LPV/r, RTV, or TDF and/or their components
  • Drug or alcohol use that, in the opinion of the investigator, would interfere with the study
  • Require therapy and/or hospitalization due to a serious infection or medical illness that is potentially life-threatening within 14 days prior to study entry
  • Any condition that, in the opinion of the investigator, would compromise ability to participate in the study
  • Unexplained fever for 7 consecutive days or chronic diarrhea within 30 days prior to study entry
  • Cancer requiring chemotherapy
  • Any immune system drugs, HIV vaccine, or other experimental therapy within 30 days prior to study entry
  • Plan to use any PI other than APV, SQV, or LPV/r in the initial study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Univ of Miami

Miami, Florida, 33136-1013, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816-2396, United States

Location

NYU/Bellevue

New York, New York, 10016, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Univ of Pittsburgh

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Univ of Texas, Galveston

Galveston, Texas, 77555-0435, United States

Location

Related Publications (3)

  • Durant J, Clevenbergh P, Garraffo R, Halfon P, Icard S, Del Giudice P, Montagne N, Schapiro JM, Dellamonica P. Importance of protease inhibitor plasma levels in HIV-infected patients treated with genotypic-guided therapy: pharmacological data from the Viradapt Study. AIDS. 2000 Jul 7;14(10):1333-9. doi: 10.1097/00002030-200007070-00005.

    PMID: 10930147BACKGROUND

  • Kilby JM, Hill A, Buss N. The effect of ritonavir on saquinavir plasma concentration is independent of ritonavir dosage: combined analysis of pharmacokinetic data from 97 subjects. HIV Med. 2002 Apr;3(2):97-104. doi: 10.1046/j.1468-1293.2002.00090.x.

    PMID: 12010356BACKGROUND

  • Veldkamp AI, van Heeswijk RP, Mulder JW, Meenhorst PL, Schreij G, van der Geest S, Lange JM, Beijnen JH, Hoetelmans RM. Steady-state pharmacokinetics of twice-daily dosing of saquinavir plus ritonavir in HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2001 Aug 1;27(4):344-9. doi: 10.1097/00126334-200108010-00004.

    PMID: 11468422BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

LopinavirRitonavirSaquinavirTenofoviramprenavir

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 ChemicalsAzolesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinolinesOrganophosphonatesOrganophosphorus CompoundsAdeninePurines

Study Officials

  • Deborah McMahon, M.D.

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 18, 2002

First Posted

September 19, 2002

Primary Completion

March 1, 2003

Last Updated

March 1, 2011

Record last verified: 2005-05

Locations

US(6)