A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Indinavir, RNA, Viral, Saquinavir, Delavirdine, Nelfinavir, Adenine, Anti-HIV Agents, Viral Load
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.
Sites / Locations
- Univ of Alabama at Birmingham
- Univ of Southern California / LA County USC Med Ctr
- UCLA CARE Ctr
- Willow Clinic
- Univ of California / San Diego Treatment Ctr
- San Francisco Gen Hosp
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
- San Mateo AIDS Program / Stanford Univ
- Stanford Univ Med Ctr
- Harbor UCLA Med Ctr
- Univ of Colorado Health Sciences Ctr
- Howard Univ
- Univ of Miami School of Medicine
- Queens Med Ctr
- Univ of Hawaii
- Northwestern Univ Med School
- Cook County Hosp
- Rush Presbyterian - Saint Luke's Med Ctr
- Louis A Weiss Memorial Hosp
- Indiana Univ Hosp
- Methodist Hosp of Indiana / Life Care Clinic
- State of MD Div of Corrections / Johns Hopkins Univ Hosp
- Johns Hopkins Hosp
- Boston Med Ctr
- Beth Israel Deaconess - West Campus
- Univ of Minnesota
- SUNY / Erie County Med Ctr at Buffalo
- Beth Israel Med Ctr
- Bellevue Hosp / New York Univ Med Ctr
- Chelsea Ctr
- Cornell Univ Med Ctr
- St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
- Mount Sinai Med Ctr
- Univ of Rochester Medical Center
- Univ of North Carolina
- Univ of Cincinnati
- Ohio State Univ Hosp Clinic
- Univ of Pennsylvania at Philadelphia
- Univ of Pittsburgh Med Ctr
- Brown Univ School of Medicine
- Julio Arroyo
- Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
- Univ of Texas Galveston
- Univ of Washington