Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women
An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) and Selected Protease Inhibitor (PI) and Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) Therapies Among HIV-Infected Women
2 other identifiers
interventional
76
2 countries
32
Brief Summary
The purpose of this study is to look at the level of depo-medroxyprogesterone acetate (DMPA or Depo-Provera) in the blood to see if is affected by certain anti-HIV drugs (nelfinavir \[NFV\], efavirenz \[EFV\], indinavir \[IDV\] in combination with ritonavir \[RTV\], and nevirapine \[NVP\]). This study will also look at the levels of these anti-HIV drugs to see if they are affected by DMPA. DMPA is a hormonal birth control method that is given as an injection. It is not known if taking DMPA together with anti-HIV drugs changes the amount of DMPA and/or the amount of anti-HIV drugs in the blood. If higher levels of DMPA occur, side effects may increase. If lower levels of anti-HIV drugs occur, the drugs may become less effective against HIV. This study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications are used together.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Jun 2001
Typical duration for not_applicable hiv-infections
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2001
CompletedStudy Start
First participant enrolled
June 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedNovember 2, 2012
October 1, 2012
May 18, 2001
October 31, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have plasma HIV-1 RNA (level of HIV in the blood) below 10,000 copies/ml within 30 days before study entry.
- Had their last menstrual period (LMP) less than 35 days before study entry.
- Have serum follicle-stimulating hormone below 40 MIU/ml if their LMP occurred more than 35 days before study entry.
- Have been on the same anti-HIV drugs for at least 30 days before study entry, if taking anti-HIV drugs. If not taking anti-HIV drugs, patients must have been told about anti-HIV drugs within the 3 months before study entry and have chosen not to take them now or in the future.
- Intend to continue on their anti-HIV drugs, if taking them, for at least 3 months after study entry.
- Have a CD4 cell count above 200 cells/mm3 if taking anti-HIV drugs, or a CD4 cell count above 350 cells/mm3 if not taking anti-HIV drugs, within 30 days before study entry.
- Have not had menopause (change of life) and have a normal reproductive system.
- Have not had any infections or AIDS-related diseases requiring drugs within 14 days before study entry.
- Are 13 years of age or older.
- Are female.
- Have a negative pregnancy test within 30 days before study entry.
- Agree to avoid becoming pregnant for the entire study. If sexually active, agree to use at least 1 barrier method of birth control (male or female condom with or without spermicide \[a cream or gel that kills sperm\] or diaphragm or cervical cap with spermicide) while receiving DMPA in this study.
- Have consent of a parent or guardian if under 18 years of age.
- +1 more criteria
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have taken anti-HIV drugs within 30 days before study entry but have chosen not to take them.
- Are taking only 1 NRTI.
- Are taking anti-HIV drugs other than those listed in the treatment groups, including tenofovir, amprenavir, and lopinavir/ritonavir, or have taken tenofovir, amprenavir, or lopinavir/ritonavir within 30 days before study entry.
- Have taken ZDV and d4T together within 30 days before study entry.
- Are not able to take the anti-HIV drugs properly while on the study, in the opinion of the investigator.
- Are allergic to DMPA, MPA, or any of the other ingredients in DMPA.
- Have received DMPA within 180 days before study entry.
- Have received other hormones (Provera, oral contraceptives, hormonal replacement therapy, or anabolic drugs \[e.g., nandrolone decanoate, megestrol acetate\]) within 30 days before study entry.
- Are taking any of the following: amiodarone, astemizole, bepridil, buspirone, carbamazepine, cimetidine, cisapride, clarithromycin, cyclosporine, dihydroergotamine, diltiazem, ergotamine, erythromycin, flecainide, glucocorticoids, grapefruit juice, St. John's wort, itraconazole, ketoconazole, lovastatin, midazolam, nefazodone, phenobarbital, phenytoin, pimozide, pioglitazone, propafenone, propofol, quinidine, rifabutin, rifampin, rosiglitazone, simvastatin, tacrolimus, terfenadine, ticlopidine, triazolam, or verapamil.
- Have taken any of the following drugs within 30 days before study entry: amiodarone, astemizole, bepridil, buspirone, carbamazepine, cisapride, clarithromycin, cyclosporine, dihydroergotamine, ergotamine, erythromycin, flecainide, glucocorticoids, St. John's wort, itraconazole, ketoconazole, lovastatin, midazolam, nefazodone, phenobarbital, phenytoin, pimozide, pioglitazone, propafenone, propofol, quinidine, rifabutin, rifampin, rosiglitazone, simvastatin, tacrolimus, terfenadine, ticlopidine, or triazolam.
- Have started, stopped, or changed doses, within 30 days before study entry, of certain drugs including: benzodiazepines, except midazolam and triazolam; bupropion; calcium channel blockers, except diltiazem and verapamil; fluconazole; lipid-lowering drugs except pravastatin (i.e., atorvastatin, cerivastatin, and fluvastatin, but not lovastatin and simvastatin); isoniazid; mexiletine; zaleplon; and zolpidem. The patient can, however, remain on stable doses of these drugs during the study.
- Are receiving methadone maintenance treatment for less than 60 days before study entry.
- Are breast-feeding.
- Have had a baby within 30 days before study entry.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612, United States
Chicago Childrens Memorial Hosp (Pediatric)
Chicago, Illinois, 60614-3394, United States
The Univ of Chicago Childrens Hosp
Chicago, Illinois, 60637, United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202-5250, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201, United States
Boston Med Ctr (Pediatric)
Boston, Massachusetts, 02118, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Community Health Network, Inc
Rochester, New York, 14642-0001, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Univ of North Carolina
Chapel Hill, North Carolina, 27514, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106-5083, United States
MetroHealth Med Ctr
Cleveland, Ohio, 44109-1998, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Univ of Washington
Seattle, Washington, 98104, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371, United States
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (1)
Watts DH, Park JG, Cohn SE, Yu S, Hitti J, Stek A, Clax PA, Muderspach L, Lertora JJ. Safety and tolerability of depot medroxyprogesterone acetate among HIV-infected women on antiretroviral therapy: ACTG A5093. Contraception. 2008 Feb;77(2):84-90. doi: 10.1016/j.contraception.2007.10.002. Epub 2007 Dec 21.
PMID: 18226670RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Susan Cohn