PI Vs. NNRTI Based Therapy for HIV Advanced Disease

• Status: Unknown status
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Ritonavir boosted protease inhibitor based therapy will have equivalent antiviral efficacy over 48 weeks compared to NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with CD4 counts ≤ 200/mm3.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: Instituto Mexicano del Seguro Social; National Council of Science and Technology, Mexico
• Treatments: Efavirenz; Lamivudine; Lopinavir; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

• HIV infected individuals

• Men or women at least 18 years old

• CD4+ T cells ≤200/ml

• Antiretroviral naive

Exclusion Criteria:

• Suspected or documented active, untreated HIV 1 related opportunistic infection (OI) or other condition requiring acute therapy (e.g., hepatitis C virus infection)

• Platelet count < 75,000 cells/mm3.

• Hemoglobin < 9 g/dL .

• AST and/or ALT greater than 5 times the upper limit of normal

• Documented or suspected active tuberculosis