PI Vs. NNRTI Based Therapy for HIV Advanced Disease

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Unknown; Phase 4

Conditions: Acquired Immunodeficiency Syndrome

Treatments: Drug: zidovudine + lamivudine + efavirenz; Drug: zidovudine+lamivudine+lopinavir/ritonavir

Study type: Interventional

Funder types: Other

Identifiers

NCT00162643

SALUD-2003-C01-123

Details and patient eligibility

About

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.

Full description

Current guidelines for initial therapy in HIV infection recommend 2 NRTIs plus either a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor (NNRTI). Recent data suggests that the rate of response to PI based therapy may be slightly compromised if the baseline CD4 count is ≤ 200/mm3 and the plasma HIV-1-RNA ≥ 100,000 copies/mL. This may not be equally apparent if ritonavir boosted protease inhibitors are used. The effect of baseline CD4 count and HIV-1-RNA levels on the antiviral efficacy of NNRTI based regimens has been less well characterized. A significant number of patients currently initiate therapy at late stages of progression, typically with baseline CD4 count is ≤ 200/mm3. In Mexico approximately 60% of patients who initiate therapy are within this range of CD4 cell counts. Currently, the two combinations recommended as preferred are with two NRTIs and either Efavirenz or Lopinavir/ritonavir, while other combinations of PIs and ritonavir are considered alternative.

Comparison: The efficacy of ritonavir boosted protease inhibitor based therapy versus NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with a CD4 count ≤ 200/mm3.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)