CompletedPhase 3

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment

Austria, Belgium, Denmark274 participantsStarted 2012-03-15

Plain-language summary

The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.

Who can participate

Age range

18 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 infection * receiving HAART for at least 48 weeks * Have at least 2 documented plasma HIV-1 RNA \<50 copies/mL, and no HIV-1 RNA \>=50 copies/mL in the 48 weeks prior to the screening * Be taking the same antiretroviral (ARV) combination for at least 8 weeks before screening * Have the preference, together with the physician, to change the current HAART regimen for reasons of simplification and/or toxicity Exclusion Criteria: * Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA \>500 copies/mL while on previous or current antiretroviral therapy * Has a history of any primary PI mutations * Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency) * Is diagnosed with acute viral hepatitis at screening or before Baseline 1 * Is co-infected with hepatitis B

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)

Timeframe: Week 48

Trial details

NCT IDNCT01448707

SponsorJanssen-Cilag International NV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06-11

Results submitted2015-10-30

View on ClinicalTrials.gov More Human Immunodeficiency Virus (HIV) Infections trials