|
Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women Clinical research trials and Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women. Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women clinical trial. Subjects often receive the most expert healthcare possible for their Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women  Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women
Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: DMPA, an injectable depot formulation of medroxyprogesterone (MPA), is a commonly used form of "progestin-only" contraception. Information is limited on the specific P450 isozymes that metabolize MPA; however, it appears that CYP3A4 is 1 pathway of hepatic clearance. Drugs known to be inhibitors of the CYP3A4 pathway (such as protease inhibitors [PIs]) may lead to elevated concentrations of MPA. Secondly, MPA given as DMPA injections has been shown to induce the activity of CYP3A4 by 25 percent. It is possible that this action may result in enhanced clearance of the substrates of CYP3A4, including PIs and nonnucleoside reverse transcriptase inhibitors (NNRTIs), which in turn may result in reduced drug exposure and possible ARV failure. This study is designed to address the lack of information on potential interactions between PIs or NNRTIs and DMPA. Patients are enrolled into 1 of 5 arms based on their current ARV regimen: Arm A (control group): No current ARVs or receiving nucleoside reverse transcriptase inhibitors (NRTIs) only. Arm B: NFV (1250 mg bid or 750 mg tid) in combination with NRTIs. Arm C: EFV (600 mg qd) in combination with NRTIs. Arm D: IDV (800 mg bid) and RTV (100 mg bid or 200 mg bid) in combination with NRTIs. Arm E: NVP (200 mg bid) in combination with NRTIs. Acceptable NRTIs and any fixed combination of these medications include: zidovudine (ZDV), lamivudine, didanosine, stavudine (d4T), zalcitabine, and abacavir; concurrent therapy using ZDV and d4T is not allowed. ARV therapy is not provided by this study. One dose of DMPA is provided to all patients at entry (Day 0) and an optional dose of DMPA will be available at the final visit (Week 12) for those who are interested in continuing with DMPA outside of the protocol and who do not experience adverse events from the first DMPA injection. Patients in Arms B, C, D, and E have intensive pharmacokinetic sampling done at entry and at Week 4 to measure ARV levels. All patients have blood tests at Weeks 2, 4, 6, 8, 10, and 12 to measure levels of DMPA and progesterone. In addition, tests to monitor HIV-1 RNA levels, CD4 and CD8 counts, hematology, blood chemistries, and liver function are performed periodically.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria 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. - Weigh at least 40 kg (88 lbs) and are within a certain range of their ideal body weight. Exclusion Criteria 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. - Have had their uterus or both ovaries removed. - Abuse drugs or alcohol. - Cannot stop drinking alcohol 1 day before and during the testing at entry and at Week 4. - Have had a change in smoking habits within 6 weeks before study entry. Patients may have either stopped or started smoking more than 6 weeks before study entry. - Have cancer of the reproductive system, vaginal bleeding of unknown cause, thyroid problems, liver tumors, or serious eye problems at any time before study entry. - Are taking investigational drugs without approval of the protocol chair.
Total Enrollment: 76
Location and Contact Information:
Overall Study Official:
SusanCohn, Study Chair,
Community Health Network, Inc
Rochester, New York, 14642-0001
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of North Carolina
Chapel Hill, North Carolina, 27514
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202-5250
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106-5083
United States
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
United States
MetroHealth Med Ctr
Cleveland, Ohio, 44109-1998
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
Boston Med Ctr (Pediatric)
Boston, Massachusetts, 02118
United States
Chicago Childrens Memorial Hosp (Pediatric)
Chicago, Illinois, 60614-3394
United States
The Univ of Chicago Childrens Hosp
Chicago, Illinois, 60637
United States
Univ of Washington
Seattle, Washington, 98104
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Additional Information:
Study ID Numbers: ACTG A5093;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016601
Other Hiv Infections Studies:
1. Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines
2. A Study of the Effects of Advantage 24 on the Rectum
3. Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
4. A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC
5. Effects of Storage on Lactate in Blood Samples
Related Studies:
Other HIV Infections Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women
|
|
|
|
|
|
|
|
