A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Fai… (NCT00931463) | Clinical Trial Compass
CompletedPhase 4
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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested second-line HIV treatment options for people whose first regimen with an NNRTI plus two other drugs stopped working — is this the same situation I'm in, and does that make this trial's results relevant to my care?
2The trial measured how many people had an undetectable viral load (under 200 copies/mL) at 48 weeks — based on those results, how do the two combination regimens tested here compare to what you'd recommend for me as a second-line option?
3Since this is a Phase 4 trial, meaning it was done after the drugs were already approved, does that mean we have a clearer picture of the safety profile of these combinations, and are there any side effects from this trial I should know about before considering similar regimens?
4The trial is now completed — are the findings published, and can you walk me through what the results showed so we can talk about whether either of those second-line approaches makes sense for my situation?
5Before considering a second-line regimen like the ones studied here, should I first do resistance testing to see exactly why my current treatment failed, and would those results change which option might work best for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization
. 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