Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women
- Conditions
- HIV Infections
- Registration Number
- NCT00016601
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
Wishard Hosp
🇺🇸Indianapolis, Indiana, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
🇺🇸Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Chicago Childrens Memorial Hosp (Pediatric)
🇺🇸Chicago, Illinois, United States
Univ of Maryland, Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
Boston Med Ctr (Pediatric)
🇺🇸Boston, Massachusetts, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, United States
Univ of Texas Galveston
🇺🇸Galveston, Texas, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
The Univ of Chicago Childrens Hosp
🇺🇸Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Community Health Network, Inc
🇺🇸Rochester, New York, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
🇺🇸Rochester, New York, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico