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NCT00000944 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants

A Phase 1 study of HIV Infections and Pregnancy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
4
Study locations

NCT00000944 is a Phase 1 study of HIV Infections and Pregnancy that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT00000944, a Phase 1 study of HIV Infections and Pregnancy, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this study is to determine if a combination anti-HIV drug treatment regimen of indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in reducing the chances of passing HIV from mother to child. This study will also examine if this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC plus ZDV is safe for newborns. Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs in this study may be more effective than ZDV alone.

Conditions Studied

HIV Infections Pregnancy

Interventions

  • DRUG Zidovudine
  • DRUG Lamivudine
  • DRUG Indinavir sulfate

Study Locations (4)

New York

  • Jacobi Med. Ctr. - The Bronx
  • Montefiore Med. Ctr. - AECOM - The Bronx

California

  • UCSF Pediatric AIDS CRS - San Francisco

Massachusetts

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases - Boston

Trial Details

FieldValue
Enrollment Target 24 participants
Est. Completion 2003-03
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00000944

The ClinicalTrials.gov registry entry for NCT00000944 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 (95% 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 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Zidovudine is the first listed.

NCT00000944 reports 4 study locations spanning 3 distinct geographic areas - top geographies include New York, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00000944 about?

NCT00000944 is a clinical study titled "A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants". The purpose of this study is to determine if a combination anti-HIV drug treatment regimen of indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in reducing the chances of passing HIV from mother to child. This study will also examine if this combination is well t...

What is the current status of trial NCT00000944?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. Estimated completion is 2003-03.

What conditions does trial NCT00000944 study?

This clinical trial studies the following conditions: HIV Infections, Pregnancy.

What interventions are being tested in trial NCT00000944?

The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Indinavir sulfate (DRUG).

Who is sponsoring clinical trial NCT00000944?

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 NCT00000944 being conducted?

This trial has 4 study locations across California, Massachusetts, New York. 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.