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PI Vs. NNRTI Based Therapy for HIV Advanced Disease

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00162643
Enrollment
300
Registered
2005-09-13
Start date
2004-12-31
Completion date
2007-12-31
Last updated
2006-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immunodeficiency Syndrome

Keywords

Acquired Immunodeficiency Syndrome, Antiretroviral Therapy, Highly Active, Protease Inhibitors, Reverse Transcriptase Inhibitors

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.

Interventions

DRUGzidovudine+lamivudine+lopinavir/ritonavir
DRUGzidovudine + lamivudine + efavirenz

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks

Secondary

MeasureTime frame
Clinical symptoms
CD4 counts
plasma Viral Load change from baseline
Tolerability
Discontinuations
Safety

Countries

Mexico

Contacts

Primary ContactJuan G Sierra-Madero, MD
jsmadero@yahoo.com5255-56559675
Backup ContactAngelina Villasis-Keever, MD MSc
avkeever@prodigy.net.mx5255-56559675

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026