Status:
COMPLETED
Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients
Lead Sponsor:
Abbott
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a K...
Eligibility Criteria
Inclusion
- Antiretroviral naïve
- HIV RNA \<100,000 copies/mL
- CD4 cell count \>100 cells/mL at screening
- with Karnofsky Score \> 70
- If female,
- non-pregnant and
- not breastfeeding
- No AIDS opportunistic infection within 30 days of screening
Exclusion
- Subject with an HIV primo-infection status
- Recent history of drug and/or alcohol abuse
- History of psychiatric illness
- If presence of the following mutations :
- in the protease : one among 32,47,48,50,82,84,90
- OR more than 3 mutations from the other points of the LPV mutation score:10,20,24,46,53,54,63,71
- in the reverse transcriptase : 215 or 184.
- If abnormal laboratory results such as :
- Hb\<8 g/dl
- Absolute neutrophil count\<750 cells/µl
- Platelet count\<50 000/ml
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00234923
Start Date
August 1 2003
Last Update
April 3 2008
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