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

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Efavirenz; HIV Protease Inhibitors; Indinavir; Medroxyprogesterone; Medroxyprogesterone Acetate; Nelfinavir; Nevirapine; Protease Inhibitors; Reverse Transcriptase Inhibitors; Ritonavir

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.