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Depot medroxyprogesterone acetate in combination with a twice-daily lopinavir-ritonavir-based regimen in HIV-infected women showed effective contraception and a lack of clinically significant interactions, with good safety and tolerability: results of the ACTG 5283 study.

Publication ,  Journal Article
Luque, AE; Cohn, SE; Park, J-G; Cramer, Y; Weinberg, A; Livingston, E; Klingman, KL; Aweeka, F; Watts, DH
Published in: Antimicrob Agents Chemother
April 2015

We conducted an open-label, steady-state pharmacokinetic (PK) study of drug-drug interactions between depot medroxyprogesterone acetate (DMPA) and twice-daily lopinavir (LPV) plus low-dose ritonavir (RTV) (LPV/r) among 24 HIV-infected women and compared the results to those for HIV-infected women receiving DMPA while on no antiretroviral therapy or on nucleosides only (n = 14 subjects from the control arm of AIDS Clinical Trials Group [ACTG] study 5093). The objectives of the study were to address the effect of LPV/r on DMPA and to address the effect of DMPA on LPV/r therapy. PK parameters were estimated using noncompartmental analysis with between-group comparisons of medroxyprogesterone acetate (MPA) PKs and within-subject comparisons of LPV and RTV PKs before and 4 weeks after DMPA dosing. Plasma progesterone concentrations were measured every 2 weeks after DMPA dosing through week 12. Although the MPA area under the concentration-time curve and maximum concentration of drug in plasma were statistically significantly increased in the study women on LPV/r compared to those in the historical controls, these increases were not considered clinically significant. There were no changes in LPV or RTV exposure after DMPA. DMPA was well tolerated, and suppression of ovulation was maintained. (This study has been registered at ClinicalTrials.gov under registration no. NCT01296152.).

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Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

April 2015

Volume

59

Issue

4

Start / End Page

2094 / 2101

Location

United States

Related Subject Headings

  • Young Adult
  • Ritonavir
  • Progesterone
  • Ovulation
  • Middle Aged
  • Microbiology
  • Medroxyprogesterone Acetate
  • Lopinavir
  • Humans
  • HIV Protease Inhibitors
 

Citation

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Luque, A. E., Cohn, S. E., Park, J.-G., Cramer, Y., Weinberg, A., Livingston, E., … Watts, D. H. (2015). Depot medroxyprogesterone acetate in combination with a twice-daily lopinavir-ritonavir-based regimen in HIV-infected women showed effective contraception and a lack of clinically significant interactions, with good safety and tolerability: results of the ACTG 5283 study. Antimicrob Agents Chemother, 59(4), 2094–2101. https://doi.org/10.1128/AAC.04701-14
Luque, Amneris E., Susan E. Cohn, Jeong-Gun Park, Yoninah Cramer, Adriana Weinberg, Elizabeth Livingston, Karin L. Klingman, Francesca Aweeka, and D Heather Watts. “Depot medroxyprogesterone acetate in combination with a twice-daily lopinavir-ritonavir-based regimen in HIV-infected women showed effective contraception and a lack of clinically significant interactions, with good safety and tolerability: results of the ACTG 5283 study.Antimicrob Agents Chemother 59, no. 4 (April 2015): 2094–2101. https://doi.org/10.1128/AAC.04701-14.

Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

April 2015

Volume

59

Issue

4

Start / End Page

2094 / 2101

Location

United States

Related Subject Headings

  • Young Adult
  • Ritonavir
  • Progesterone
  • Ovulation
  • Middle Aged
  • Microbiology
  • Medroxyprogesterone Acetate
  • Lopinavir
  • Humans
  • HIV Protease Inhibitors