A placebo-controlled pilot study of intensification of antiretroviral therapy with mycophenolate mofetil
2006

Pilot Study on Mycophenolate Mofetil and Antiretroviral Therapy

Sample size: 6 publication Evidence: low

Author Information

Author(s): Kaur Rupinderjeet, Bedimo Roger, Kvanli Mary Beth, Turner Diana, Shaw Leslie, Margolis David

Primary Institution: University of Texas Southwestern Medical Center at Dallas

Hypothesis

Can mycophenolate mofetil improve virologic suppression in patients with low-level viremia while on antiretroviral therapy?

Conclusion

Mycophenolate mofetil appears safe and may reduce T cell activation, but its effect on viral load suppression was inconclusive due to adherence issues.

Supporting Evidence

  • All subjects randomized to placebo elected to cross over to open label MMF.
  • No significant adverse events were observed during MMF therapy.
  • Three patients on MMF achieved VL < 50 copies/mL by week 4.
  • Cell surface markers of apoptosis, activation, and proliferation on CD4+ and CD8+ cells declined modestly or remained low.

Takeaway

This study tested a new medicine to see if it could help people with HIV who are already taking other medicines. It seemed safe, but it was hard to tell if it really worked because some people didn't take their medicine as they should.

Methodology

Patients were given either mycophenolate mofetil or placebo while on stable antiretroviral therapy, and their viral loads and immune responses were monitored over 24 weeks.

Potential Biases

Potential bias due to the small number of participants and the crossover design.

Limitations

The small sample size and issues with patient adherence limited the ability to draw definitive conclusions.

Participant Demographics

HIV-infected patients on stable antiretroviral therapy with low-level viremia.

Digital Object Identifier (DOI)

10.1186/1742-6405-3-16

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