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NCT00016601 · ClinicalTrials.gov registry record · NA
Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women
A NA study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
- 20
- Study locations
NCT00016601: Completed NA study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00016601 is a NA study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 76 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00016601, a NA study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Efavirenz
- DRUG Indinavir sulfate
- DRUG Nelfinavir mesylate
- DRUG Nevirapine
Study Locations (20)
Illinois
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics - Chicago
- Univ of Illinois College of Medicine / Pediatrics - Chicago
- Chicago Childrens Memorial Hosp (Pediatric) - Chicago
- The Univ of Chicago Childrens Hosp - Chicago
Indiana
- Indiana Univ Hosp - Indianapolis
- Methodist Hosp of Indiana / Life Care Clinic - Indianapolis
- Wishard Hosp - Indianapolis
New York
- Beth Israel Med Ctr - New York
- Columbia Presbyterian Med Ctr - New York
- Community Health Network, Inc - Rochester
California
- Univ of Southern California / LA County USC Med Ctr - Los Angeles
- Los Angeles County - USC Med Ctr - Los Angeles
Florida
- Univ of Florida Health Science Ctr / Pediatrics - Jacksonville
- Univ of Miami (Pediatric) - Miami
Alabama
- Univ of Alabama at Birmingham - Birmingham
Colorado
- Children's Hosp of Denver - Denver
Louisiana
- Tulane Univ / Charity Hosp of New Orleans - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2001-06 |
| Est. Completion | 2004-05 |
| Phase | NA |
What the finished NCT00016601 record still lists
NCT00016601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (83% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Ritonavir is the first listed.
NCT00016601 names 20 study sites across 11 states, led by Illinois, Indiana, New York.
Frequently Asked Questions
What is clinical trial NCT00016601 about?
NCT00016601 is a clinical study titled "Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women". 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 stu...
What is the current status of trial NCT00016601?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2001-06. Estimated completion is 2004-05.
What conditions does trial NCT00016601 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00016601?
The interventions under investigation include: Ritonavir (DRUG), Efavirenz (DRUG), Indinavir sulfate (DRUG), Nelfinavir mesylate (DRUG), Nevirapine (DRUG).
Who is sponsoring clinical trial NCT00016601?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00016601 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00016601's enrollment target sits among peer trials
76 303rd of 542 higher than 238 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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