Activity of the Soft Gelatin Capsule of Saquinavir (SQVsgc) in Combination With Ritonavir or Nelfinavir and Combinations of Delavirdine and/or Adefovir Dipivoxil in HIV-Infected Subjects With Prior Indinavir Use and Viral Loads From 2,000 to 200,000 Copies HIV RNA/ml

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:

Required:

- Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients who have a CD4
cell count of equal or less than 200 cells/mm3.

Allowed:

- Topical and oral antifungal agents except ketoconazole and itraconazole.

- Treatment, maintenance or chemoprophylaxis with approved agents for opportunistic
infections.

- Antibiotics.

- Systemic corticosteroids for 21 days or less for acute problems.

- Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF,
filgrastim).

- Regularly prescribed medications such as antipyretics, analgesics, allergy
medications, antidepressants, sleep medications, oral contraceptives (not as a sole
form of birth control), megestrol acetate, or testosterone.

- Alternative therapies, such as vitamins, acupuncture, and visualization techniques.

- [AS PER AMENDMENT 3/30/98: Calcium channel blockers may be used only with caution.]

Patients must have:

- HIV-1 infection documented by a licensed ELISA and confirmed by Western blot, HIV
culture, HIV antigen, plasma HIV RNA, or a second antibody test other than ELISA.

- 2,000 to 200,000 HIV-1 RNA copies/ml as measured by any Roche-certified laboratory
[AS

PER AMENDMENT 3/30/98:

- using the Roche Amplicor HIV-1 Monitor] within 30 days of study entry.

- Signed, informed consent from parent or legal guardian for patients less than 18
years of age.

Prior Medication: Required:

- More than 6 months cumulative indinavir therapy.

- Stable indinavir-containing antiretroviral regimen for at least 4 weeks [2 weeks AS
PER AMENDMENT 3/30/98] prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Any active infection requiring acute treatment within 30 days [21 days AS PER
AMENDMENT 3/30/98] prior to study entry.

- Unexplained temperature greater than 38.5 degrees for any 7 consecutive days within
30 days prior to study entry.

- Malignancy, including Kaposi's sarcoma, that requires systemic chemotherapy.

Concurrent Medication:

Excluded:

- Non-protocol-specified immunomodulatory and/or antiretroviral agents.

- Systemic cytotoxic chemotherapy.

- Ketoconazole, itraconazole, rifampin, rifabutin, alprazolam, amiodarone, astemizole,
bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, encainide,
estazolam, flecainide, flurazepam, isotretinoin, meperidine, midazolam, piroxicam,
propafenone, propoxyphene, quinidine, terfenadine, triazolam, zolpidem, phenytoin,
phenobarbital, carbamazepine, and ergot alkaloids and [ AS PER AMENDMENT 3/30/98:
dexamethasone, ergot derivatives, and pimozide].

Avoided:

- Herbal medications.

Prior Medication:

Excluded:

- At least 2 weeks or more total ritonavir and/or saquinavir (hard gelatin capsule).

- NNRTIs (nevirapine, delavirdine, DMP-266, etc.), saquinavir (soft gelatin capsule),
nelfinavir, 141W94VX-478, and adefovir dipivoxil.

- Immunomodulator [systemic immunomodulator AS PER AMENDMENT 3/30/98] or
investigational drug therapy within 30 days prior to entry.

- Active immunization within 30 days [21 days AS PER AMENDMENT 3/30/98] prior to entry.