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Completed

NCT Number: NCT00931463

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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Interzonal General de Agudos, Oscar Alende, Buenos Aires, Mar Del Plata Provincia, Argentina

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About this study

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:

I. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

raltegravir

Drug

400 mg raltegravir tablet taken every 12 hours

Other names: Isentress

2N(t)RTI

Drug

2N(t)RTIs as prescribed

Other names: nucleosides, nucleotides, nuncleoside backbone

Ritonavir-boosted lopinavir

Drug

2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours

Other names: Aluvia, Kaletra

Primary outcomes

  1. Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization

    Time frame: 48 weeks following randomization

Secondary outcomes

  1. Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population

    Time frame: 48 weeks

    The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment

  2. Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure

    Time frame: 48 weeks

    The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures:

    i. week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy

  3. 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

    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

  4. 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

    The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • Abbott
  • Merck Sharp & Dohme LLC
  • amfAR, The Foundation for AIDS Research

Registry information

Official study 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

Acronym: SECOND-LINE

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jul 2, 2009
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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