HIV InfectionsPhase 4SECOND-LINENCT00931463
A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen
A Phase 4 study testing raltegravir, 2N(t)RTI and Ritonavir-boosted lopinavir in people with HIV Infections, run by Kirby Institute at 44 sites in 17 countries.
Trial summary
The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- raltegravir, 2N(t)RTI and Ritonavir-boosted lopinavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 44 sitesin 17 countries
- Study dates
- Sep 2009to Aug 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-1 positive by licensed diagnostic test
- Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate)
- Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for at least 24 weeks
- No change in antiretroviral therapy within 12 weeks prior to screening
- Failed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (at least 7 days apart) HIV RNA results of greater then 500 copies/mL
- No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors
- Able to provide written informed consent
Who cannot join
- The following laboratory variables:
- absolute neutrophil count (ANC) < 500 cells/microlitres
- hemoglobin < 7.0 g/decilitres
- platelet count < 50,000 cells/microlitres
- ALT great than 5 x ULN
- Pregnant or nursing mothers
Show all 13Show fewer
- Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
- Use of immunomodulators within 30 days prior to screening
- Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
- Intercurrent illness requiring hospitalization
- Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator
- Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study
- Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
Trial locations and contacts
44 sites in 17 countries.
44 sites in 17 countries
Argentina10 sites
Hospital Interzonal General de Agudos, Oscar Alende
Buenos Aires, Mar Del Plata Provincia, 1900
CAICI
Buenos Aires, Rosario Provincia de Sante Fe, 2000
Hospital General de Agudos 'Teodoro Alvarez'
Buenos Aires, 1406
FUNCEI
Buenos Aires
Hospital de Infecciosas FJ Muniz
Buenos Aires
Hospital Italiano
Buenos Aires
Hospital J.M. Ramos Mejia
Buenos Aires
Hospital Prof. Alejandro Posadas
Buenos Aires
Hospital Rawson
Córdoba
Hospital Central
Mendoza, 5500
Australia5 sites
Liverpool Hospital
Liverpool, New South Wales, 2170
The Alfred Hospital
Melbourne, Victoria, 3004
Centre Clinic
Melbourne, Victoria, 3182
Albion Street Centre
Sydney, New South Wales, 2010
St Vincent's Hospital
Sydney, New South Wales, 2010
Peru4 sites
Hospital Almenara
Lima
IMPACTA/Hospital Dos de Mayo
Lima
Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia
Lima
Via Libre
Lima
Malaysia3 sites
Hospital Pelau Pinang
Kuala Lumpur
Hospital Sungai Buloh
Kuala Lumpur
University of Malaysia
Kuala Lumpur
Mexico3 sites
Hospital General de Guadalajara
Guadalajara
Hospital General de Leon
León
Instituto Nacional de Ciencias Medicas y Nutricion "Salvado Zubiran"
Mexico City
Nigeria3 sites
Evangel Hospital (ECWA)
Jos, Plateau State
Jos University Teaching Hospital (JUTH)
Jos, Plateau State
Plateau State Specialist Hospital
Jos, Plateau State
South Africa3 sites
Josha Research
Bloemfontein
Desmond Tutu HIV Foundation
Cape Town
Chris Hani Baragwanath Hospital
Soweto
Chile2 sites
Hospital de la Universidad Catolica Pontificia
Santiago
Hospital San Borja-Arriaran
Santiago
United Kingdom1 site
Chelsea and Westminster Hospital
Fulham, London, SW10 9NH
About this study
Official title: A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy
The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir.
The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.
The primary endpoint is virological: a comparison of virological suppression in plasma < 200 copies/mL between the randomized arms after 48 weeks.
Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.
Read the detailed description
In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2N(t)RTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e., non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3N(t)RTIs.
Eligible patients will be randomised to one of two arms:
- ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTIs
II. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400 mg twice daily
The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of participants with HIV RNA < 200 copies/mL 48 weeks after randomisation.
Secondary objectives include virological, immunological, safety and antiretroviral therapy endpoints.
Exploratory endpoints include clinical, metabolic, drug resistance, medication adherence and quality of life endpoints.
- Conditions
- HIV Infections
- Being tested
- raltegravir, 2N(t)RTI, Ritonavir-boosted lopinavir
- Keywords
- second line therapy, combination antiretroviral therapy, first-line failure, AIDS, treatment experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raltegravirDrug
Also called Isentress
400 mg raltegravir tablet taken every 12 hours
2N(t)RTIDrug
Also called nucleosides, nucleotides, nuncleoside backbone
2N(t)RTIs as prescribed
Ritonavir-boosted lopinavirDrug
Also called Aluvia, Kaletra
2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Ritonavir-boosted lopinavir and 2N(t)RTI | Active comparator | This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines. Receives: Drug: 2N(t)RTI; Drug: Ritonavir-boosted lopinavir |
| Ritonavir-boosted lopinavir and raltegravir | Experimental | This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable. Receives: Drug: raltegravir; Drug: Ritonavir-boosted lopinavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization
Measured: 48 weeks following randomization
Secondary outcomes (4)
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population
The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment
Measured: 48 weeks
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure
The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures:
- week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy
Measured: 48 weeks
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL
The difference between treatment arms in proportion of participants with plasma HIV RNA < 200 copies/mL 48 weeks after randomization, per-protocol population: stratified analysis by baseline plasma viral load (less than or equal to 100,000 copies per mL or >100,000 copies per mL) on those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment
Measured: 48 weeks
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL
The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC, Abbott, amfAR, The Foundation for AIDS Research
- Responsible party
- Sponsor
- Investigators
- David A Cooper, MD, Study chair, Kirby InstituteBrian Gazzard, MD, Study chair, St. Stephen's Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931463
- Sponsor's protocol ID
- SECOND-LINE
- Acronym
- SECOND-LINE
- Status last verified
- Aug 2019
- First submitted
- 1 Jul 2009
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Henry RT, Jiamsakul A, Law M, Losso M, Kamarulzaman A, Phanuphak P, Kumarasamy N, Foulkes S, Mohapi L, Nwizu C, Wood R, Kelleher A, Polizzotto M; SECOND-LINE Study Group. Factors Associated With and Characteristic of HIV/Tuberculosis Co-Infection: A Retrospective Analysis of SECOND-LINE Clinical Trial Participants. J Acquir Immune Defic Syndr. 2021 May 1;87(1):720-729. doi: 10.1097/QAI.0000000000002619.
PubMed 33399309Amin J, Boyd MA, Kumarasamy N, Moore CL, Losso MH, Nwizu CA, Mohapi L, Kerr SJ, Sohn AH, Teppler H, Renjifo B, Molina JM, Emery S, Cooper DA. Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection. PLoS One. 2015 Feb 27;10(2):e0118228. doi: 10.1371/journal.pone.0118228. eCollection 2015.
PubMed 25723472Martin A, Moore CL, Mallon PW, Hoy JF, Emery S, Belloso WH, Phanuphak P, Ferret S, Cooper DA, Boyd MA; Second-Line Study Team. HIV lipodystrophy in participants randomised to lopinavir/ritonavir (LPV/r) +2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTI) or LPV/r + raltegravir as second-line antiretroviral therapy. PLoS One. 2013 Oct 30;8(10):e77138. doi: 10.1371/journal.pone.0077138. eCollection 2013.
PubMed 24204757SECOND-LINE Study Group; Boyd MA, Kumarasamy N, Moore CL, Nwizu C, Losso MH, Mohapi L, Martin A, Kerr S, Sohn AH, Teppler H, Van de Steen O, Molina JM, Emery S, Cooper DA. Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study. Lancet. 2013 Jun 15;381(9883):2091-9. doi: 10.1016/S0140-6736(13)61164-2.
PubMed 23769235
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy
- ClinicalTrials.gov ID
- NCT00931463
- Acronym / sponsor ID
- SECOND-LINE / SECOND-LINE
- Conditions
- HIV Infections
- Keywords
- second line therapy, combination antiretroviral therapy, first-line failure, AIDS, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Merck Sharp & Dohme LLC, Abbott, amfAR, The Foundation for AIDS Research
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 17 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir.
The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.
The primary endpoint is virological: a comparison of virological suppression in plasma < 200 copies/mL between the randomized arms after 48 weeks.
Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.
Detailed description
In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2N(t)RTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e., non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3N(t)RTIs.
Eligible patients will be randomised to one of two arms:
- ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTIs
II. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400 mg twice daily
The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of participants with HIV RNA < 200 copies/mL 48 weeks after randomisation.
Secondary objectives include virological, immunological, safety and antiretroviral therapy endpoints.
Exploratory endpoints include clinical, metabolic, drug resistance, medication adherence and quality of life endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ritonavir-boosted lopinavir and 2N(t)RTI | Active comparator | Drug: 2N(t)RTI, Drug: Ritonavir-boosted lopinavirThis is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines. |
| Ritonavir-boosted lopinavir and raltegravir | Experimental | Drug: raltegravir, Drug: Ritonavir-boosted lopinavirThis is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-1 positive by licensed diagnostic test
- Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate)
- Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for at least 24 weeks
- No change in antiretroviral therapy within 12 weeks prior to screening
- Failed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (at least 7 days apart) HIV RNA results of greater then 500 copies/mL
Key exclusion criteria (13 listed)
- The following laboratory variables:
- Pregnant or nursing mothers
- Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
- Use of immunomodulators within 30 days prior to screening
- Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
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 |
|---|---|---|
| raltegravirAlso: Isentress400 mg raltegravir tablet taken every 12 hours | Drug | Ritonavir-boosted lopinavir and raltegravir |
| 2N(t)RTIAlso: nucleosides, nucleotides, nuncleoside backbone2N(t)RTIs as prescribed | Drug | Ritonavir-boosted lopinavir and 2N(t)RTI |
| Ritonavir-boosted lopinavirAlso: Aluvia, Kaletra2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours | Drug | Ritonavir-boosted lopinavir and 2N(t)RTI, Ritonavir-boosted lopinavir and raltegravir |
Primary outcome
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization
Time frame: 48 weeks following randomization
4 secondary outcomes
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population
Time frame: 48 weeks
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure
Time frame: 48 weeks
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL
Time frame: 48 weeks
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33399309Henry RT, Jiamsakul A, Law M, Losso M, Kamarulzaman A, Phanuphak P, Kumarasamy N, Foulkes S, Mohapi L, Nwizu C, Wood R, Kelleher A, Polizzotto M; SECOND-LINE Study Group. Factors Associated With and Characteristic of HIV/Tuberculosis Co-Infection: A Retrospective Analysis of SECOND-LINE Clinical Trial Participants. J Acquir Immune Defic Syndr. 2021 May 1;87(1):720-729. doi: 10.1097/QAI.0000000000002619.
- Derived from this study: PubMed 25723472Amin J, Boyd MA, Kumarasamy N, Moore CL, Losso MH, Nwizu CA, Mohapi L, Kerr SJ, Sohn AH, Teppler H, Renjifo B, Molina JM, Emery S, Cooper DA. Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection. PLoS One. 2015 Feb 27;10(2):e0118228. doi: 10.1371/journal.pone.0118228. eCollection 2015.
- Derived from this study: PubMed 24204757Martin A, Moore CL, Mallon PW, Hoy JF, Emery S, Belloso WH, Phanuphak P, Ferret S, Cooper DA, Boyd MA; Second-Line Study Team. HIV lipodystrophy in participants randomised to lopinavir/ritonavir (LPV/r) +2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTI) or LPV/r + raltegravir as second-line antiretroviral therapy. PLoS One. 2013 Oct 30;8(10):e77138. doi: 10.1371/journal.pone.0077138. eCollection 2013.
- Derived from this study: PubMed 23769235SECOND-LINE Study Group; Boyd MA, Kumarasamy N, Moore CL, Nwizu C, Losso MH, Mohapi L, Martin A, Kerr S, Sohn AH, Teppler H, Van de Steen O, Molina JM, Emery S, Cooper DA. Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study. Lancet. 2013 Jun 15;381(9883):2091-9. doi: 10.1016/S0140-6736(13)61164-2.
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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.
David A Cooper, MD study chair
Kirby Institute
Brian Gazzard, MD study chair
St. Stephen's Trust
44 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing raltegravir, 2N(t)RTI and Ritonavir-boosted lopinavir in people with HIV Infections, run by Kirby Institute at 44 sites in 17 countries.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Argentina, Australia, Peru, Malaysia, Mexico and 12 more countries. 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?
Yes. Results are posted in the registry (first posted 17 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization (time frame: 48 weeks following randomization). 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 NCT00931463, which also lists 4 linked publications.
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 27 Mar 2026.