Search / Trial NCT00002193

Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Hiv 1 Drug Therapy, Combination Hiv Protease Inhibitors Rna, Viral Vx 478 Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

ClinConnect Summary

In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children \< 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Your child may be eligible for this study if he/she:
  • Is 6 months - 18 years of age.
  • Is HIV-positive.
  • Has a viral load (level of HIV in the body) greater than 10,000 copies/ml.
  • Is able to take medications by mouth.
  • Has consent of parent or legal guardian if under 18.
  • Has a negative pregnancy test within 7 days of study entry.
  • Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study.
  • Exclusion Criteria
  • Your child will not be eligible for this study if he/she:
  • Has a serious illness, including any life-threatening infection or other chronic serious medical condition.
  • Has an opportunistic (AIDS-related) infection or a serious bacterial infection.
  • Is allergic to NRTIs.
  • Is breast-feeding.
  • Is unlikely to complete the study.
  • Has received certain medications.
  • Has received radiation therapy within the past 4 months, or will need to receive it during the study.

About Glaxo Wellcome

Glaxo Wellcome, a leading global biopharmaceutical company, is dedicated to advancing healthcare through innovative research and development of new therapies. With a strong focus on addressing unmet medical needs, Glaxo Wellcome combines scientific excellence with a commitment to improving patient outcomes across various therapeutic areas, including respiratory, infectious diseases, and oncology. The company is recognized for its robust clinical trial portfolio, leveraging cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. Glaxo Wellcome upholds the highest ethical standards in clinical research, ensuring patient safety and integrity throughout the trial process.

Locations

Fort Lauderdale, Florida, United States

Memphis, Tennessee, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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