HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, CD4 Lymphocyte Count, Nelfinavir, Anti-HIV Agents
Brief summary
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.)
Interventions
DRUGNelfinavir mesylate
Sponsors
Agouron Pharmaceuticals
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed