Acquired Immunodeficiency SyndromePhase 4NCT00162643
PI Vs. NNRTI Based Therapy for HIV Advanced Disease
A Phase 4 study testing zidovudine+lamivudine+lopinavir/ritonavir and zidovudine + lamivudine + efavirenz in people with Acquired Immunodeficiency Syndrome, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 5 sites in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- zidovudine+lamivudine+lopinavir/ritonavir and zidovudine + lamivudine + efavirenz
- How many people
- 300 participants
- Where
- 5 sitesMexico
- Study dates
- Dec 2004to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected individuals
- Men or women at least 18 years old
- CD4+ T cells ≤200/ml
- Antiretroviral naive
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Mexico5 sites, 5 recruiting
- Recruiting
Hospital General Regional de Leon
León, Guanajuato
Juan L Mosqueda-Gomez, MD, 5255-4771310037, luis_mosqueda@yahoo.com
Juan L Mosqueda-Gomez, MD
- Recruiting
Hospital General Regional #53
Los Reyes Acaquilpan, State of Mexico, 56400
Patricia Mendez-Cardos, MD, 5255-5855 4414 ext. 238, kalekbuda74@yahoo.com
Patricia Mendez-Cardos, MD
- Recruiting
Hospital de Especialidades Centro Medico Nacional siglo XXI
Mexico City, D.F., 06720
Leticia M Perez-Saleme, MD, 5255-56-27 69 00 ext. 21547, lepesa@prodigy.net.mx
Leticia M Perez-Saleme, MD
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
Angelina Villasis-Keever, MD MSc, 5255-56559675, avkeever@prodigy.net.mx
Luis E. Soto-Ramirez, MD, 5255-56559675, lsoto@quetzal.innsz.mx
- Recruiting
Hospital General Regional #72
Tlalnepantla, State of Mexico, 54000
Fernanda Gutierrez-Escolano, MD MSc, 5255-5565 9210 ext. 320, fernandamx@yahoo.com
Pueblito Pizano-Gonzalez, MD, 5255-5565 9210 ext. 320
About this study
Official title: Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease
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.
Read the 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.
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- zidovudine+lamivudine+lopinavir/ritonavir, zidovudine + lamivudine + efavirenz
- Keywords
- Acquired Immunodeficiency Syndrome, Antiretroviral Therapy, Highly Active, Protease Inhibitors, Reverse Transcriptase Inhibitors
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zidovudine+lamivudine+lopinavir/ritonavirDrug
zidovudine + lamivudine + efavirenzDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
Secondary outcomes (6)
plasma Viral Load change from baseline
Clinical symptoms
CD4 counts
Safety
Tolerability
Discontinuations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startDec 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico, Instituto Mexicano del Seguro Social
- Investigators
- Juan G Sierra-Madero, MD, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162643
- Sponsor's protocol ID
- SALUD-2003-C01-123
- Status last verified
- Sep 2006
- First submitted
- 7 Sep 2005
- Last updated
- 14 Sep 2006
- Results posted
- No
Publications
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.
PubMed 24805184
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease
- ClinicalTrials.gov ID
- NCT00162643
- Acronym / sponsor ID
- SALUD-2003-C01-123
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- Acquired Immunodeficiency Syndrome, Antiretroviral Therapy, Highly Active, Protease Inhibitors, Reverse Transcriptase Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico, Instituto Mexicano del Seguro Social
- Study start
- Dec 2004
- Study completion
- Dec 2007
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infected individuals
- Men or women at least 18 years old
- CD4+ T cells ≤200/ml
- Antiretroviral naive
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zidovudine+lamivudine+lopinavir/ritonavir | Drug | – |
| zidovudine + lamivudine + efavirenz | Drug | – |
Primary outcome
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
6 secondary outcomes
plasma Viral Load change from baseline
Clinical symptoms
CD4 counts
Safety
Tolerability
Discontinuations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2006.
- Derived from this study: PubMed 24805184Lima 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan G Sierra-Madero, MD study chair
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zidovudine+lamivudine+lopinavir/ritonavir and zidovudine + lamivudine + efavirenz in people with Acquired Immunodeficiency Syndrome, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 5 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan G Sierra-Madero, MD (5255-56559675, jsmadero@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00162643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2006.