Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Lamivudine; Lamivudine, zidovudine drug combination; Lopinavir; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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