Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients
NCT00234923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138
Last updated 2008-04-03
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 Kaletra three drug standard of care reference arm
Conditions
- HIV Infection
Interventions
- DRUG
-
lopinavir/ritonavir
400 mg lopinavir/ 100 mg ritonavir, BID
- DRUG
-
lamivudine/zidovudine
300mg lamivudine/150mg zidovudine, BID
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Medical Information · Abbott
Study Design
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-08-31
- Primary Completion
- 2007-02-28
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