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A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection - Article


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Ketotifen Fumarate Ophthalmic

ketotifen fumarate; Zaditor


Clinical Trial: A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

This study has been completed.

Sponsored by: Gilead Sciences
Information provided by: AIDS Clinical Trials Information Service

Purpose

This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.

Condition Treatment or Intervention
HIV Infections
 Drug: Tenofovir disoproxil fumarate

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment

Official Title: An Open-Label, Multicenter, Compassionate Access Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination with Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients

Further Study Details: 

Expected Total Enrollment:  300

Study start: December 1999

HIV-1-infected patients who are currently receiving stable antiretroviral therapy add tenofovir DF to their regimen. Study participation lasts for approximately 48 weeks. Interested patients should contact their physicians.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have a viral load greater than or equal to 10,000 copies/ml.
  • Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.)
  • Are at least 18 years old.
  • Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward.
  • Have a life expectancy of at least one year.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have a history of a serious kidney or bone disease.
  • Have severe nausea, vomiting, or trouble taking medications by mouth.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine.
  • Are taking any medicines that interfere with kidney functions.

Location Information


California
      Tenofovir Coordinating Center, Foster City,  California,  94404,  United States

More Information

Study ID Numbers:  283C; GS-99-908
Record last reviewed:  May 2000
Last Updated:  October 13, 2004
Record first received:  January 24, 2000
ClinicalTrials.gov Identifier:  NCT00002453
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 7, 2008



Page Updated: September 6, 2005
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