Clinical trial NCT00162643: PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Official title: Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acquired Immunodeficiency Syndrome
Keywords: Acquired Immunodeficiency Syndrome
Antiretroviral Therapy, Highly Active
Protease Inhibitors
Reverse Transcriptase Inhibitors
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
name: Instituto Mexicano del Seguro Social
First posted: 2005-09-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
Secondary outcomes:
measure: plasma Viral Load change from baseline
measure: Clinical symptoms
measure: CD4 counts
measure: Safety
measure: Tolerability
measure: Discontinuations
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital de Especialidades Centro Medico Nacional siglo XXI
state: D.f.
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
city: Los Reyes La Paz
country: Mexico
facility: Hospital General Regional #53
state: Estado de Mexico
city: Tlalnepantla
country: Mexico
facility: Hospital General Regional #72
state: Estado de Mexico
city: Leon
country: Mexico
facility: Hospital General Regional de Leon
state: Guanajuato
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Juan G Sierra-Madero, MD
role: STUDY_CHAIR
References:
citation: Lima VD, Sierra-Madero J, Wu Z, Singer J, Wood E, Hull MW, Richard Harrigan P, Montaner JS. Comparing the efficacy of efavirenz and boosted lopinavir using viremia copy-years. J Int AIDS Soc. 2014 May 6;17(1):18617. doi: 10.7448/IAS.17.1.18617. eCollection 2014.