Search / Trial NCT00000859

A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Hiv 1 Drug Resistance Drug Therapy, Combination Hiv Protease Inhibitors Cd4 Lymphocyte Count Ritonavir Indinavir Disease Progression Rna, Viral Genotype Nelfinavir Anti Hiv Agents Viral Load

Description

AR therapy is rapidly becoming the standard of care for the treatment of HIV infection. AR therapy provides the best opportunity for maximizing viral suppression, reducing toxicity and delaying the emergence of resistant strains. The newest class of AR agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a population with advanced HIV disease, who are taking various background nucleoside therapies. Eligible patients will be randomized either to NFV plus backgro...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Background AR nucleoside therapy is required, although background AR therapy may also be no background therapy. However, the use of protease inhibitors is not recommended as monotherapy unless there is no other alternative. Therefore, patients who are not on AR treatment may be enrolled at the discretion of the clinician.
  • Allowed:
  • Saquinavir.
  • Patients must have:
  • Documented HIV infection.
  • A CD4+ cell count <= 100/mm3 within 3 months prior to the study. [AS PER AMENDMENT 3/11/98: CD4+ cell count <= 200/mm3 any time prior to entry].
  • Parental consent if patient is < 18 years old.
  • Prior Medication:
  • Allowed:
  • Saquinavir (SQV).
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Stage 2 or greater AIDS dementia complex.
  • [AS PER AMENDMENT 10/2/97: Any acute disease or condition that would, in the physician's judgement, contraindicate starting NFV or RTV.]
  • Known hypersensitivity to RTV or any of its ingredients (for patients assigned to RTV therapy).
  • Concurrent Medication:
  • Excluded:
  • Concomitant use of protease inhibitors.
  • Concomitant treatments that cannot be discontinued, and in the physician's judgement, should not be taken with NFV or RTV.
  • AS PER AMENDMENT 10/2/97:
  • For patients randomized to NFV:
  • Concomitant therapy with terfenadine, astemizole, cisapride, triazolam, midazolam, ergot derivatives, amiodarone, quinidine, or rifampin.
  • For patients randomized to IDV:
  • Concomitant therapy with terfenadine, astemizole, cisapride, triazolam, midazolam, and rifampin.
  • Patients with any of the following prior symptoms are excluded:
  • AS PER AMENDMENT 10/2/97:
  • History of clinically significant hypersensitivity reaction to any component of NFV tablets (for patients assigned to NFV therapy).
  • Prior Medication:
  • Excluded:
  • Prior use of protease inhibitors except SQV.
  • [AS PER AMENDMENT 10/2/97:
  • Prior use of IDV for more than 4 weeks or other protease inhibitors (except SQV) for any prior duration.]

Attachments

readout_NCT00000859_2024-03-02.pdf

4.5 MB

NCT00000859_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Francisco, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Detroit, Michigan, United States

Camden, New Jersey, United States

Newark, New Jersey, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Richmond, Virginia, United States

Toronto, Ontario, Canada

San Francisco, California, United States

Portland, Oregon, United States

Baltimore, Maryland, United States

Albuquerque, New Mexico, United States

Denver, Colorado, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

New Orleans, Louisiana, United States

Rockville, Maryland, United States

Detroit, Michigan, United States

Camden, New Jersey, United States

Camden, New Jersey, United States

Newark, New Jersey, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Vancouver, British Columbia, Canada

Halifax, Nova Scotia, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Ste Foy, Quebec, Canada

Saskatoon, Saskatchewan, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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