Pharmacokinetic Interactions Between DMPA and LPV/r Among HIV-Infected Women

Completed · Phase 2

Conditions studied: HIV-1 Infection

In brief

This study was done to look at the level of Depo-Provera, an injectable birth control, in the blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir \[LPV/r\]). It is not known whether taking Depo-Provera together with Kaletra changes the amount of Kaletra in blood. Therefore, this study also looked at the levels of HIV and Kaletra before and after receiving a shot of Depo-Provera. This study evaluated the safety of Depo-Provera and Kaletra when they are used together. In addition to what is stated above, this study also explored any effect of Depo-Provera on the immune system.

Key facts

Study ID

NCT01296152

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

25

Starts

2011-05-01

Expected to finish

2012-10-01

Last updated by the study team

2015-12-22

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection
• Documentation of plasma HIV-1 RNA </= 400 copies/mL within 30 days prior to study entry.
• Last menstrual period </= 35 days prior to study entry.
• If last menstrual period >35 days prior to study entry, serum follicle-stimulating hormone (FSH) must be </= 40 Milli-International units per Milliliter (MIU/mL)
• Stable anti-retroviral (ARV) regimen consisting of BID LPV/r plus 2 or more nucleoside reverse transcriptase inhibitors (NRTIs) for at least 30 days if postpartum or for at least the previous 14 days if on a previously stable antiretroviral regimen without modifications prior to study entry
• Cluster of Differentiation 4 (CD4+) cell count ≥200 cells/mm\^3 within 30 days prior to study entry
• Certain laboratory values within 30 days prior to study entry
• Premenopausal females with normal ovarian function
• Negative serum or urine-Human Chorionic Gonadotropin (HCG) pregnancy test within 72 hours prior to study entry
• All subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or in vitro fertilization) for the duration of the study.Subjects of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to use an additional reliable method of contraception while in the study.
• Ability and willingness to give written informed consent
• Documentation of Pap smear within one year prior to study entry.
• Documentation of hepatitis B (surface antigen) and hepatitis B (core antibody) and hepatitis C (antibody) status prior to study entry.
• Documentation of varicella-zoster virus (VZV) status by history of varicella or herpes zoster, or history of varicella or herpes zoster vaccination or documentation of anti-VZV antibodies.
• Willingness to abstain from alcohol 24 hours prior to and during the 10-hour pharmacokinetic (PK) specimen draws.
• Willingness to abstain from any grapefruit product or supplement for 24 hours prior to entry and for the duration of the study.

You may not qualify if…

• Received DMPA within 180 days prior to study entry.
• Received other hormonal therapies within the 30 days prior to study entry.
• Concurrent dual nucleoside therapy of zidovudine (ZDV) and stavudine (d4T) within 30 days prior to study entry.
• Use of any prohibited medications within 30 days prior to study entry. Prohibited Medications were:
• amiodarone (Cordarone)
• astemizole (Hismanal)
• bepridil (Vascor)
• carbamazepine (Tegretol)
• cisapride (Propulsid)
• clarithromycin (Biaxin)
• cyclosporine (Sandimmune, Neoral)
• dihydroergotamine (Migranal and others)
• ergotamine (Ergostat, Gotamine, and others)
• erythromycin (E-mycin, erythromycin ethylsuccinate (EES) and others)
• flecainide (Tambocor)
• glucocorticoids
• Hypericum perforatum (St. John's wort)
• itraconazole (Sporanox)
• ketoconazole (Nizoral)
• lovastatin (Mevacor)
• midazolam (Versed)
• nefazadone (Serzone)
• phenobarbital (Luminal)
• phenytoin (Dilantin)
• pimozide (Orap)

Where it is running

• University of Southern California LA (5048) — Los Angeles, California, United States
• Children's National Medical Center Washington DC NICHD CRS (5015) — Washington D.C., District of Columbia, United States
• Washington Hospital Center NICHD CRS (5023) — Washington D.C., District of Columbia, United States
• South Florida Childrens Diagnostic & Treatment Cen (5055) — Fort Lauderdale, Florida, United States
• Northwestern University CRS (2701) — Chicago, Illinois, United States
• Rush University Cook County Hospital Chicago NICHD CRS (5083) — Chicago, Illinois, United States
• Tulane University New Orleans NICHD CRS (5095) — New Orleans, Louisiana, United States
• Univ. of Rochester ACTG CRS (1101) — Rochester, New York, United States
• SUNY Stony Brook NICHD CRS (5040) — Stony Brook, New York, United States
• Unc Aids Crs (3201) — Chapel Hill, North Carolina, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Univ. of Cincinnati CRS (2401) — Cincinnati, Ohio, United States
• University of Washington AIDS CRS (1401) — Seattle, Washington, United States
• San Juan Hospital PR NICHD CRS (5031) — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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