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Viracept Expanded Access Program



Viracept Expanded Access Program

For Condition: HIV Infections
Status: Completed
Sponsor(s): Agouron Pharmaceuticals ,
Synopsis: To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients who are unable to take the three commercially available protease inhibitors (because of failure, intolerance, or contraindication) and who have a CD4 cell count of <= 50. To obtain additional information on the safety profile of nelfinavir mesylate (Viracept). (PER AMENDMENT 1/8/97: People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. - CD4 T cell count <= 100 cells/mm3. - Failed, been intolerant of or had a contraindication to all three commercially available protease inhibitors (saquinavir, indinavir and ritonavir). (PER AMENDMENT 1/8/97: - People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.) Exclusion Criteria Prior Medication: Excluded: Prior therapy with Viracept. Required: - Indinavir. - Saquinavir. - Ritonavir.
Total Enrollment: 

Location and Contact Information:

Agouron Pharmaceuticals Inc
San Diego,  California,  92121
United States
 


Additional Information:
Study ID Numbers:
  259B;  Study 515,AG1343 - 515
Study Start Date: 
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002165

Other Hiv Infections Studies:
1. Antiviral Activity of and Resistance to Lamivudine in Combination with Zidovudine, Stavudine, or Didanosine

2. A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3

3. Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

4. A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT

5. A Study to Monitor Patients with Primary or Early HIV Infection

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Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials

Viracept Expanded Access Program

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