A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir

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

Keywords

ClinConnect Summary

While indinavir is currently the most commonly prescribed protease inhibitor, the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown. Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure. This may involve the use of 1 or more reverse transc...

Gender

ALL

Eligibility 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.