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Home > "A" Clinical Trials Conditions > A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir  A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir
A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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. Patients are stratified by HIV RNA (2,000 - 20,000 copies/ml versus 20,000 - 200,000 copies/ml), and randomized to 1 of 6 treatment arms as follows: Arm A: Saquinavir (SQV) plus ritonavir (RTV) plus delavirdine (DLV) plus adefovir dipivoxil placebo. Arm B: SQV plus RTV plus DLV placebo plus adefovir dipivoxil. Arm C: SQV plus RTV plus DLV plus adefovir dipivoxil. Arm D: SQV plus nelfinavir (NFV) plus DLV plus adefovir dipivoxil placebo. Arm E: SQV plus NFV plus DLV placebo plus adefovir dipivoxil. Arm F: SQV plus NFV plus DLV plus adefovir dipivoxil. In addition to assigned study treatment patients receive an L-carnitine supplement. Therapy is administered for 24 weeks. Patients who have an average HIV RNA value for Weeks 12 and 16 that is less than 5,000 copies or a least 1 log below their baseline value may continue their assigned study treatment for an additional 24 weeks. [AS PER AMENDMENT 3/30/98: Subjects with plasma HIV RNA greater than 5,000 copies/ml may elect to continue or discontinue study medications in the treatment extension and seek the best available treatment.] [AS PER AMENDMENT 06/11/98: The dose of adefovir dipivoxil is reduced at or after Week 16. Alternatively, patients may discontinue adefovir dipivoxil/placebo and substitute appropriate antiretroviral agent(s) or add appropriate antiretroviral agent(s) to their reduced-dose regimen. Also, at the discretion of the protocol chairperson, patients who have been on study for more than 16 weeks may substitute appropriate FDA-approved antiretroviral agent(s) for any study medication that must be discontinued because of toxicity. Addition of nonnucleoside reverse transcriptase inhibitors, protease inhibitors, or investigational agents is specifically excluded.]
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
RGulick, Study Chair,
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, 15213
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Brown Univ School of Medicine
Providence, Rhode Island, 02908
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York City, New York, 10021
United States
Chelsea Ctr
New York City, New York, 10021
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Willow Clinic
Menlo Park, California, 94025
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Additional Information:
Study ID Numbers: ACTG 359;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000892
Other Hiv Infections Studies:
1. A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC
2. An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
3. A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
4. Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals
5. Treatment of Acute HIV Infection to Preserve Immune Function
Related Studies:
Other HIV Infections Clinical Trials
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Other Knoxville Clinical Trials
A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir
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