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

Information source: AIDS Clinical Trials Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: depo-medroxyprogesterone acetate (Drug); Depo-medroxyprogesterone Acetate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AIDS Clinical Trials Group

Official(s) and/or principal investigator(s):
Susan E Cohn, M.D., M.P.H., Study Chair, Affiliation: Northwestern University CRS
Amneris E Luque, M.D., Study Chair, Affiliation: University of Rochester ACTG CRS

Summary

This study is being 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 will also look at the levels of HIV and Kaletra before and after receiving a shot of Depo-Provera. This study will take a look at the safety of Depo-Provera and Kaletra when they are used together. In addition to what is stated above, this study will also explore any effect of Depo-Provera on the immune system.

Clinical Details

Official title: An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate (DMPA) and Lopinavir/Ritonavir (LPV/r) and of the Effects of DMPA on Cellular Immunity and Regulation in HIV-Infected Women

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Natural log-transformed medroxyprogesterone acetate (MPA) pharmacokinetic parameter area under the concentration-time curve (AUC) obtained from this study and natural log-transformed MPA PK AUC0-12wk from the study control arm in ACTG A5093

Determine the effect of MPA on the PK of lopinavir (LPV) among HIV-infected subjects using the AUC for LPV at baseline (day 0) before MPA administration and at week 4

Secondary outcome:

Progesterone levels obtained at study weeks 0, 2, 4, 6, 8, 10, and 12 from both this current study and the study control arm in ACTG A5093

Natural log-transformed MPA PK parameters Cmin, Cmax. Tmax, T1/2, and Cl/F determined based on MPA levels obtained at study weeks 0, 2, 4, 6, 8, 10, and 12 from this current study and those from the study control arm in ACTG A5093

Natural log-transformed LPV PK parameters Cmin, Cmax, Tmax, T1/2, and Cl/F obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4

Natural log-transformed RTV PK parameters AUC0-12h, Cmin, Cmax, Tmax, and Cl/F obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4

Laboratory toxicities and signs and symptoms with toxicity grades recorded while on study. HIV-1 RNA copies at study entry and study week 12

CMI to HIV and two common opportunistic agents C. albicans (candida) and varicella-zoster virus (VZV) measured at baseline before DMPA and after DMPA at week 4 and at week 12 using flow cytometry

Tregs at baseline, week 4, and week 12 using flow cytometry in freshly thawed and in antigen-stimulated PBMCs measured at baseline before DMPA and after DMPA at week 4 and week 12 using flow cytometry

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- HIV-1 infection

- Documentation of plasma HIV-1 RNA entry.

- Last menstrual period

- If last menstrual period >35 days prior to study entry, serum follicle-stimulating

hormone (FSH) must be - Stable ARV regimen consisting of BID LPV/r plus 2 or more 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

- CD4+ cell count ≥200 cells/mm3 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-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 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 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. Exclusion Criteria:

- 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 ZDV and d4T within 30 days prior to study

entry.

- Use of any prohibited medications within 30 days prior to study entry. A list of

prohibited medications is on the study's protocol specific web page.

- Breastfeeding.

- Less than 30 days postpartum at study entry.

- Bilateral oophorectomy.

- Hypersensitivity to DMPA, MPA, or any of the other ingredients in DMPA.

- More than a 50% change in tobacco smoking within the 30 days prior to study entry or

plans to significantly change tobacco use during the study.

- Invasive cancer of the reproductive tract; known or suspected malignancy of the

breast, or known increased risk for breast cancer; undiagnosed vaginal bleeding; liver tumors; or serious ocular disorders at any time prior to study entry.

- Uncontrolled hypothyroidism or hyperthyroidism within 30 days of study entry.

- Acute infections or other opportunistic diseases requiring medication within 14 days

prior to study entry.

- Receipt of any immunizations within 2 weeks prior to enrollment.

- Use of any immunosuppressant medication including systemic corticosteroids within 30

days prior to study entry.

- Chronic immunosuppressive conditions other than HIV.

- Initiated, discontinued, or changed doses of drugs that are CYP 3A4 substrates within

30 days of study entry.

- History of deep venous thrombosis or pulmonary emboli.

Locations and Contacts

San Juan Hospital PR NICHD CRS (5031), San Juan 00936, Puerto Rico

Univ. of Alabama Birmingham NICHD CRS (5096), Birmingham, Alabama 35233, United States

University of Southern California LA (5048), Los Angeles, California 90033, United States

University of California, San Francisco (5091), San Francisco, California 94143, United States

Washington Hospital Center NICHD CRS (5023), Washington, District of Columbia 20010, United States

South Florida Childrens Diagnostic & Treatment Cen (5055), Ft. Lauderdale, Florida 33316, United States

Chicago Children's CRS (4001), Chicago, Illinois 60612, United States

Northwestern University CRS (2701), Chicago, Illinois 60611, United States

Rush University Cook County Hospital Chicago NICHD CRS (5083), Chicago, Illinois 60612, United States

WNE Maternal Pediatric Adolescent AIDS CRS (7301), Worcester, Massachusetts 01605, United States

NJ Med School CRS (2802), Newark, New Jersey 07103, United States

AIDS Care CRS (1108), Rochester, New York 14642, United States

Univ. of Rochester ACTG CRS (1101), Rochester, New York 14642, United States

SUNY Stony Brook NICHD CRS (5040), Stony Brook, New York 11794, United States

Unc Aids Crs (3201), Chapel Hill, North Carolina 27516, United States

Duke Univ. Med. Ctr. Adult CRS (1601), Durham, North Carolina 27710, United States

Univ. of Cincinnati CRS, Cincinnati, Ohio 45267-0405, United States

Univ. of Cincinnati CRS (2401), Cincinnati, Ohio 45267, United States

Additional Information

Starting date: May 2011
Last updated: June 5, 2014

Page last updated: August 23, 2015

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