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OpenTrials
Completed

NCT Number: NCT00234910

Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Medical Information-Abbott

Abbott Park, Illinois, 60064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV positive
  • >18 years of age
  • HIV RNA> 400 copies/mL
  • Any CD 4 cell count
  • Antiretroviral naïve
  • No acute illness

Exclusion criteria

-

Treatment and study plan

Tenofovir DF

Drug

TDF 300mg QD for 72 wks

lopinavir/ritonavir with 2 Nucleoside RTIs

Drug

LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks

Other names: ABT-378, Kaletra, lopinavir/ritonavir

Primary outcomes

  1. Antiviral efficacy by HIV RNA

    Time frame: 72 wks

  2. Incidence of adverse events

    Time frame: 72 wks

Secondary outcomes

  1. Adherence and quality of life

    Time frame: 72 wks

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients

Acronym: KALEAD

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Oct 10, 2005
Registry last updated
Jul 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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