PI Vs. NNRTI Based Therapy for HIV Advanced Disease

Acquired Immunodeficiency Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00162643
• Other study ID #: SALUD-2003-C01-123
• Status: Recruiting
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: September 13, 2006
• Start date: December 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2006
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: Juan G Sierra-Madero, MD
• Phone: 5255-56559675
• Email: jsmadero[@]yahoo.com
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• zidovudine+lamivudine+lopinavir/ritonavir

• zidovudine + lamivudine + efavirenz

Locations

Country	Name	City	State
Mexico	Hospital General Regional de Leon	Leon	Guanajuato
Mexico	Hospital General Regional #53	Los Reyes La Paz	Estado de Mexico
Mexico	Hospital de Especialidades Centro Medico Nacional siglo XXI	Mexico City	D.f.
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City	DF
Mexico	Hospital General Regional #72	Tlalnepantla	Estado de Mexico

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Instituto Mexicano del Seguro Social, National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who reach HIV-1-RNA = 50 copies/mL at 48 weeks
Secondary	plasma Viral Load change from baseline
Secondary	Clinical symptoms
Secondary	CD4 counts
Secondary	Safety
Secondary	Tolerability
Secondary	Discontinuations