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OpenTrials
Completed

NCT Number: NCT00648999

Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Site Ref # / Investigator 4074, León, Guanajauto, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV Infected subjects
  • Subjects failing in current HIV treatment, or
  • Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.

Exclusion criteria

  • Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
  • Subject is pregnant

Treatment and study plan

Lopinavir/ritonavir

Drug

lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment

Other names: ABT-378, Kaletra

Primary outcomes

  1. Quality of Life

    Time frame: Baseline, Week 4, Week 24 and Week 48

  2. CD4

    Time frame: Baseline, Week 24 and Week 48

Secondary outcomes

  1. Adverse Event Monitoring

    Time frame: Baseline, Week 4, Week 24 and Week 48

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Apr 1, 2008
Registry last updated
Mar 15, 2013

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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