drugset / Trial / NCT00125983
Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women
Phase 2
Completed
32 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · collab
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The purpose of this study is to examine the drug interactions between a protease inhibitor (PI)-based regimen including lopinavir/ritonavir (LPV/r) and two forms of contraceptive medications in HIV infected women.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2007-01
Publications
- Background Mildvan D, Yarrish R, Marshak A, Hutman HW, McDonough M, Lamson M, Robinson P. Pharmacokinetic interaction between nevirapine and ethinyl estradiol/norethindrone when administered concurrently to HIV-infected women. J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):471-7. doi: 10.1097/00126334-200204150-00007.
- Background Ouellet D, Hsu A, Qian J, Locke CS, Eason CJ, Cavanaugh JH, Leonard JM, Granneman GR. Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers. Br J Clin Pharmacol. 1998 Aug;46(2):111-6. doi: 10.1046/j.1365-2125.1998.00749.x.
- Background Audet MC, Moreau M, Koltun WD, Waldbaum AS, Shangold G, Fisher AC, Creasy GW; ORTHO EVRA/EVRA 004 Study Group. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA. 2001 May 9;285(18):2347-54. doi: 10.1001/jama.285.18.2347.
- Results Vogler MA, Patterson K, Kamemoto L, Park JG, Watts H, Aweeka F, Klingman KL, Cohn SE. Contraceptive efficacy of oral and transdermal hormones when co-administered with protease inhibitors in HIV-1-infected women: pharmacokinetic results of ACTG trial A5188. J Acquir Immune Defic Syndr. 2010 Dec;55(4):473-82. doi: 10.1097/QAI.0b013e3181eb5ff5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Loestrin | Unknown | — | Oral |
| Subject | Lopinavir | Other / unclassified | 400 mg | — |
| Subject | ORTHO EVRA | Unknown | — | Other |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |