Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Delayed-Action Preparations, Drug Interactions, Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Indinavir, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, Medroxyprogesterone 17-Acetate, efavirenz
Eligibility 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.
Sites / Locations
- Univ of Alabama at Birmingham
- Univ of Southern California / LA County USC Med Ctr
- Los Angeles County - USC Med Ctr
- Children's Hosp of Denver
- Univ of Florida Health Science Ctr / Pediatrics
- Univ of Miami (Pediatric)
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
- Univ of Illinois College of Medicine / Pediatrics
- Chicago Childrens Memorial Hosp (Pediatric)
- The Univ of Chicago Childrens Hosp
- Indiana Univ Hosp
- Methodist Hosp of Indiana / Life Care Clinic
- Wishard Hosp
- Tulane Univ / Charity Hosp of New Orleans
- Univ of Maryland, Institute of Human Virology
- Boston Med Ctr (Pediatric)
- Children's Hosp of Michigan
- Beth Israel Med Ctr
- Columbia Presbyterian Med Ctr
- Community Health Network, Inc
- St Mary's Hosp (Univ of Rochester/Infectious Diseases)
- Univ of Rochester Medical Center
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
- Univ of North Carolina
- Univ of Cincinnati
- Case Western Reserve Univ
- MetroHealth Med Ctr
- Univ of Pennsylvania
- Univ of Texas Galveston
- Univ of Washington
- Children's Hospital & Medical Center / Seattle ACTU
- San Juan City Hosp