NCT00075231

Brief Summary

The purpose of this study is to determine whether a simplified lopinavir-ritonavir based therapy will continue to keep the viral load to very low levels after initial treatment with a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 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

December 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2004

Completed
Last Updated

October 2, 2006

Status Verified

September 1, 2006

First QC Date

January 6, 2004

Last Update Submit

September 28, 2006

Conditions

HIV Infections

Keywords

Treatment Naive

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.

Interventions

Kaletra® (lopinavir/ritonavir)DRUG
Combivir® (lamivudine, zidovudine)DRUG
Sustiva® (efavirenz)DRUG

Eligibility Criteria

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

You may qualify if:

  • Subject is at least 18 years of age.
  • Subject is confirmed HIV positive and in the investigator's opinion requires antiretroviral (ARV) therapy.
  • Subject is naïve to HIV ARV therapy or has received \< 7 days total of any HIV ARV therapy \> 30 days prior to study drug administration.
  • Subject's HIV RNA is \>= 1000 copies/mL at screening.
  • If sexually active, subject agrees to use safe sex practices to reduce risk of HIV transmission (e.g., male or female condom, vaginal dam, etc.).
  • If female, the results of a urine pregnancy test performed at screening and on Day 1/Baseline are both negative.
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
  • A. Condoms, sponge, foams, jellies, diaphragm or intrauterine device.
  • B. A vasectomized partner.
  • C. Total abstinence from sexual intercourse.
  • Subject is not breastfeeding.
  • Subject's vital signs, physical examination, and laboratory results do not exhibit evidence of acute illness.
  • Subject has a Karnofsky score greater than or equal to 70.
  • Subject agrees not to take any drugs during the study, including over-the-counter medicines, vitamins, mineral supplements, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the investigator.
  • Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of initiating study drug.
  • +1 more criteria

You may not qualify if:

  • A subject will be excluded from the study if he/she meets any of the following criteria:
  • Subject has a history of an allergic reaction or significant sensitivity to lopinavir, ritonavir, lamivudine, zidovudine, efavirenz, or to any inert materials contained in the study drug formulations.
  • Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease that would, in the opinion of the investigator, adversely affect his/her participation in this study.
  • Subject is currently taking any drug (medicinal or herbal) that is contraindicated and/or not to be co-administered with any of the three study drugs as defined in the current locally approved prescribing information.
  • Subject has a history of drug and/or alcohol abuse or psychiatric illness that in the investigator's opinion could preclude compliance with the protocol.
  • Subject is receiving immunomodulatory agents, colony stimulating factor, bone marrow stimulants (e.g., erythropoietin \[Procrit®, Epogen®\] or filgrastim \[Neupogen®\]), ganciclovir, interferon-alpha, and other bone marrow suppressive or cytotoxic agents.
  • The TRUGENE HIV-1 resistance report indicates resistance or possible resistance to the study reverse transcriptase inhibitor(s) \[RTI(s)\] (efavirenz, lamivudine or zidovudine) OR the presence of any mutation in the protease gene leading to an amino acid substitution at the following loci: 8, 30, 32, 46, 47, 48, 50, 54, 82, 84, or 90 OR four or more mutations at the following loci: 10, 20, 24, 36, 53, 63, or 71.
  • Screening laboratory analyses show any of the following abnormal laboratory results: Presence of Hepatitis B surface antigen (HBsAg); Hemoglobin \<= 9.5 g/dL; Absolute neutrophil count \<= 1000 cells/mL; Platelet count \<= 50,000 per mL; ALT (SGPT) or AST (SGOT) \>= 3.0 x Upper Limit of Normal (ULN); Fasting Triglycerides \> 750 mg/dL; Fasting Cholesterol \> 300 mg/dL; Creatinine \>= 1.5 x Upper Limit of Normal (ULN); Fasting serum glucose \> 126 mg/dL
  • Subject is taking a prescribed lipid lowering medication such as HMG-CoA Reductase Inhibitors (statin) or fibrate medications.
  • Subject has a history of diabetes mellitus.
  • Subject has received any investigational drug or vaccine within 30 days prior to study drug administration.
  • For any reason, subject is considered by the investigator to be an unsuitable candidate to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fountain Valley Regional Hospital and Medical Center

Fountain Valley, California, 92708, United States

Location

Related Publications (2)

  • Brown TT, McComsey GA, King MS, Qaqish RB, Bernstein BM, da Silva BA. Loss of bone mineral density after antiretroviral therapy initiation, independent of antiretroviral regimen. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):554-61. doi: 10.1097/QAI.0b013e3181adce44.

    PMID: 19512937DERIVED

  • Cameron DW, da Silva BA, Arribas JR, Myers RA, Bellos NC, Gilmore N, King MS, Bernstein BM, Brun SC, Hanna GJ. A 96-week comparison of lopinavir-ritonavir combination therapy followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy. J Infect Dis. 2008 Jul 15;198(2):234-40. doi: 10.1086/589622.

    PMID: 18540803DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

lopinavir-ritonavir drug combinationLopinavirRitonavirlamivudine, zidovudine drug combinationLamivudineZidovudineefavirenz

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 ChemicalsAzolesZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Officials

  • Barbara da Silva, M.D.

    Abbott

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 6, 2004

First Posted

January 8, 2004

Study Start

December 1, 2003

Last Updated

October 2, 2006

Record last verified: 2006-09

Locations

US(1)