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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 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.

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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

HIV Infections

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

FieldValue
Enrollment Target 76 participants
Start Date 2001-06
Est. Completion 2004-05
Phase NA

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00016601

The ClinicalTrials.gov registry entry for NCT00016601 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (83% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.