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HIV switch study: which combo works best after First-Line failure?

NCT ID NCT00931463

Disease control Sponsor: Kirby Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different drug combinations for people with HIV whose first treatment stopped working. 558 participants received either standard second-line drugs plus a newer integrase inhibitor (raltegravir) or the standard second-line drugs alone. The main goal was to see which combination better suppressed the virus after 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ritonavir-boosted lopinavir and raltegravir
What this could lead to
If successful, this could show that adding raltegravir is as good as or better than continuing standard nucleoside drugs for people whose first HIV treatment stopped working.
What could go wrong
This is a completed Phase 4 trial, so results are already known. The main risk is that the new combination may not be more effective or may cause different side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

558 people

The number who actually took part.

Start date

Sep 2009

Finished

Aug 2013

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. HIV-1 positive by licensed diagnostic test 2. Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate) 3. Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for at least 24 weeks 4. No change in antiretroviral therapy within 12 weeks prior to screening 5. 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 6. No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors 7. Able to provide written informed consent Exclusion Criteria: 1. 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 2. Pregnant or nursing mothers 3. Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen 4. Use of immunomodulators within 30 days prior to screening 5. Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort) 6. Intercurrent illness requiring hospitalization 7. Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator 8. Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study 9. Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • Albion Street Centre

    Sydney, New South Wales, 2010, Australia

  • Auckland Hospital

    Grafton, Auckland, 1, New Zealand

  • CAICI

    Buenos Aires, Rosario Provincia de Sante Fe, 2000, Argentina

  • Centre Clinic

    Melbourne, Victoria, 3182, Australia

  • Chelsea and Westminster Hospital

    Fulham, London, SW10 9NH, United Kingdom

  • Chris Hani Baragwanath Hospital

    Soweto, South Africa

  • Desmond Tutu HIV Foundation

    Cape Town, South Africa

  • Evangel Hospital (ECWA)

    Jos, Plateau State, Nigeria

  • FUNCEI

    Buenos Aires, Argentina

  • Hopital Saint-Louis

    Paris, France

  • Hospital Almenara

    Lima, Peru

  • Hospital Central

    Mendoza, 5500, Argentina

  • Hospital General de Agudos 'Teodoro Alvarez'

    Buenos Aires, 1406, Argentina

  • Hospital General de Guadalajara

    Guadalajara, Mexico

  • Hospital General de Leon

    León, Mexico

  • Hospital Interzonal General de Agudos, Oscar Alende

    Buenos Aires, Mar Del Plata Provincia, 1900, Argentina

  • Hospital Italiano

    Buenos Aires, Argentina

  • Hospital J.M. Ramos Mejia

    Buenos Aires, Argentina

  • Hospital Pelau Pinang

    Kuala Lumpur, Malaysia

  • Hospital Prof. Alejandro Posadas

    Buenos Aires, Argentina

  • Hospital Rawson

    Córdoba, Argentina

  • Hospital San Borja-Arriaran

    Santiago, Chile

  • Hospital Sungai Buloh

    Kuala Lumpur, Malaysia

  • Hospital de Infecciosas FJ Muniz

    Buenos Aires, Argentina

  • Hospital de la Universidad Catolica Pontificia

    Santiago, Chile

  • IMPACTA/Hospital Dos de Mayo

    Lima, Peru

  • Institute of Infectious Diseases

    Pune, Pune, India

  • Instituto Nacional de Ciencias Medicas y Nutricion "Salvado Zubiran"

    Mexico City, Mexico

  • Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia

    Lima, Peru

  • J W Goethe Universitat

    Frankfurt, Germany

  • Jos University Teaching Hospital (JUTH)

    Jos, Plateau State, Nigeria

  • Josha Research

    Bloemfontein, South Africa

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Mater Misericordiae-Dublin

    Dublin, Ireland

  • Medical Group Practice

    Berlin, Germany

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Plateau State Specialist Hospital

    Jos, Plateau State, Nigeria

  • Queen Elizabeth Hospital

    Hong Kong, Kowloon, Hong Kong

  • St Vincent's Hospital

    Sydney, New South Wales, 2010, Australia

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • University of Malaysia

    Kuala Lumpur, Malaysia

  • Via Libre

    Lima, Peru

  • YRG Care

    Chennai, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.