PI Vs. NNRTI Based Therapy for HIV Advanced Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease

Conditions
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Acquired Immunodeficiency Syndrome

Intervention / Treatment
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* Drug: zidovudine+lamivudine+lopinavir/ritonavir
* Drug: zidovudine + lamivudine + efavirenz


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zidovudine+lamivudine+lopinavir/ritonavir|nan|
|Drug: zidovudine + lamivudine + efavirenz|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma Viral Load change from baseline |  |  | 
| Clinical symptoms |  |  | 
| CD4 counts |  |  | 
| Safety |  |  | 
| Tolerability |  |  | 
| Discontinuations |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acquired Immunodeficiency Syndrome, Antiretroviral Therapy, Highly Active, Protease Inhibitors, Reverse Transcriptase Inhibitors