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

TitleDepot 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
Publication TypeJournal Article
Year of Publication2015
AuthorsLuque AE, Cohn SE, Park J-G, Cramer Y, Weinberg A, Livingston E, Klingman KL, Aweeka F, D Watts H
JournalAntimicrob Agents Chemother
Volume59
Issue4
Pagination2094-101
Date Published2015 Apr
ISSN1098-6596
KeywordsAdolescent, Contraceptives, Oral, Synthetic, Delayed-Action Preparations, Drug Interactions, Female, HIV Infections, HIV Protease Inhibitors, Humans, Lopinavir, Medroxyprogesterone Acetate, Middle Aged, Ovulation, Progesterone, Ritonavir, Young Adult
Abstract

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.).

DOI10.1128/AAC.04701-14
Alternate JournalAntimicrob. Agents Chemother.
PubMed ID25624326
PubMed Central IDPMC4356823
Grant List1U01AI068636 / AI / NIAID NIH HHS / United States
1U01AI069471 / AI / NIAID NIH HHS / United States
1U01AI069481 / AI / NIAID NIH HHS / United States
1U01AI069511 / AI / NIAID NIH HHS / United States
1U01AI069513 / AI / NIAID NIH HHS / United States
1UL1TR001111 / TR / NCATS NIH HHS / United States
AI068634 / AI / NIAID NIH HHS / United States
P30 AI027763 / AI / NIAID NIH HHS / United States
P30 AI50410 / AI / NIAID NIH HHS / United States
UL-1RR02460 / RR / NCRR NIH HHS / United States
UL1 TR000150 / TR / NCATS NIH HHS / United States
UL1 TR001111 / TR / NCATS NIH HHS / United States
UL1TR000150 / TR / NCATS NIH HHS / United States
UM1 AI068634 / AI / NIAID NIH HHS / United States
UM1 AI068636 / AI / NIAID NIH HHS / United States
UM1 AI069471 / AI / NIAID NIH HHS / United States
UM1 AI069481 / AI / NIAID NIH HHS / United States
UM1 AI069511 / AI / NIAID NIH HHS / United States
UM1 AI106701 / AI / NIAID NIH HHS / United States
UM1 AI106701 / AI / NIAID NIH HHS / United States
UM1-AI069423-08 / AI / NIAID NIH HHS / United States
UM1AI068616 / AI / NIAID NIH HHS / United States
UM1AI068632 / AI / NIAID NIH HHS / United States
UM1AI068636 / AI / NIAID NIH HHS / United States
UM1AI106716 / AI / NIAID NIH HHS / United States