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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copies/ml after 16 weeks of treatment. To assess the safety, toxicity, and tolerance of each treatment arm. 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 transcriptase inhibitors (RTIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). This study attempts to formally evaluate some of these options in indinavir-experienced patients.

Key facts

Study ID

NCT00000892

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

300

Expected to finish

1999-08-01

Last updated by the study team

2021-11-04

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Willow Clinic — Menlo Park, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
• Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Queens Med Ctr — Honolulu, Hawaii, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Louis A Weiss Memorial Hosp — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• State of MD Div of Corrections / Johns Hopkins Univ Hosp — Baltimore, Maryland, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Boston Med Ctr — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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