Pilot, Randomized Study Assessing Safety, Tolerability and Efficacy of Simplified LPV/r Maintenance Therapy in HIV Patients on the 1st PI-Based Regimen
2011

Simplified Maintenance Therapy for HIV Patients

Sample size: 80 publication 10 minutes Evidence: moderate

Author Information

Author(s): Cahn Pedro, Montaner Julio, Junod Patrice, Patterson Patricia, Krolewiecki Alejandro, Andrade-Villanueva Jaime, Cassetti Isabel, Sierra-Madero Juan, CasirĂ³ Arnaldo David, Bortolozzi Raul, Lupo Sergio Horacio, Longo Nadia, Rampakakis Emmanouil, Ackad Nabil, Sampalis John S.

Primary Institution: Fundacion Huesped, Buenos Aires, Argentina

Hypothesis

Is switching to lopinavir/ritonavir monotherapy as effective and safe as continuing standard HAART in HIV patients?

Conclusion

The virologic efficacy and safety of lopinavir/ritonavir monotherapy is comparable to that of a standard triple-drug therapy in HIV patients.

Supporting Evidence

  • 71 patients completed treatment at day 360.
  • 40 patients on LPV/r and 37 on HAART had viral loads below 200 copies/mL.
  • Most common adverse events were diarrhea (19%) and headache (18%).
  • 10% of patients on LPV/r required intensification with NRTIs, all regained virologic control.

Takeaway

This study looked at whether a simpler HIV treatment could work just as well as the usual complicated one. It found that the simpler treatment was just as good.

Methodology

A one-year, randomized, open-label, multi-center study comparing LPV/r monotherapy to standard HAART in virologically suppressed HIV-1-infected adults.

Potential Biases

The open-label design may introduce bias, but reflects real-life practice.

Limitations

The study had a small sample size and was not able to achieve the calculated sample size due to low recruitment rates.

Participant Demographics

Participants were predominantly male (84%) and Caucasian (94%), with a mean age of 39 years.

Statistical Information

P-Value

P=0.61

Confidence Interval

95% CI: 0.04–5.31

Digital Object Identifier (DOI)

10.1371/journal.pone.0023726

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication