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The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs Clinical research trials and The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs. The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs clinical trial. Subjects frequently obtain the most expert healthcare possible for their The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs  The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Steps I and II: The purpose of this study is the following: To look at how many patients achieve undetectable HIV blood levels at Week 16. To look at the absolute change in HIV blood levels from the beginning of the study to Week 16. To look at the safety and tolerability of nelfinavir (NFV) and efavirenz (EFV) when used in combination or separately in regimens containing reverse transcriptase inhibitors (RTIs). For the 2 extension studies (Weeks 49 to 144): To look at the proportion of patients whose long-term viral load remains undetectable at Week 96. To look at the time from the beginning of the study to treatment failure, with patients evaluated through Week 144. Step III: To look at the proportion of patients whose HIV blood levels are undetectable 16 weeks after starting the salvage study treatment. To assess safety, toxicity, and tolerance of salvage study drug treatment. (This study has been changed by adding new objectives.) Achieving viral suppression has been widely endorsed as the primary goal of HIV therapy. However, there are few established guidelines for devising combinations of different classes of drugs which will enhance the potential for achieving viral suppression, reducing the risk of toxicity, and preserving therapeutic options for future use. This study includes 2 anti-HIV drugs, NFV (a protease inhibitor [PI]) and EFV (a nonnucleoside reverse transcriptase inhibitor [NNRTI]), for use either alone or in combination with RTI therapy for the purpose of limiting HIV replication. Patients with treatment failure at Week 16 choose 1 of the following 3 alternative salvage therapies: 2-drug PI regimen (saquinavir and ritonavir) plus adefovir dipivoxil and L-carnitine; EFV or NFV (if not already given) plus 2 new approved anti-HIV drugs outside the study; or the best available treatment outside the study. The new RTI, adefovir dipivoxil, is added to the 2-drug PI regimen to achieve suppression of viral replication and thereby delay disease progression. (This rationale reflects a change in the treatment given to patients with treatment failure at Week 16.)
Details: Achieving viral suppression has been widely endorsed as the primary goal of HIV therapy, yet there are few established guidelines to provide the framework by which to devise combinations of different classes of drugs which will not only enhance the potential for achieving viral suppression while reducing the risk of toxicity but will also preserve therapeutic options for future use. This study includes 2 antiretroviral compounds, NFV (a protease inhibitor [PI]) and EFV (a nonnucleoside reverse transcriptase inhibitor [NNRTI]), for use either alone or in combination with reverse transcriptase inhibitor (RTI) therapy for the purpose of limiting HIV replication. [AS PER AMENDMENT 3/5/98: Patients who experience treatment failure at Week 16 or later choose 1 of the following alternative potent salvage therapy regimens: a dual-PI regimen (saquinavir/ritonavir) plus adefovir dipivoxil and L-carnitine; EFV or NFV (if not already given) plus 2 new approved antiretroviral drugs outside the study; or the best available treatment outside the study. The new reverse transcriptase inhibitor, adefovir dipivoxil, is added to the dual-PI regimen to achieve suppression of viral replication and thereby delay disease progression.] Step I: Patients with detectable plasma HIV RNA levels are assigned to Group A, and those with undetectable levels are assigned to Group B (control). Group A: Patients are randomized to 1 of 3 treatment arms: NFV plus EFV placebo on Arm I; NFV placebo plus EFV on Arm II; or NFV plus EFV on Arm III. Concurrent with their randomly assigned therapy, patients receive open-label RTI therapy comprising 1 of the following 3 combinations that provides 1 or 2 new RTIs: didanosine (ddI) plus stavudine (d4T); lamivudine (3TC) plus d4T; or ddI plus 3TC. [AS PER AMENDMENT 12/02/97: Patients with virologic failure at Week 16 seek the best available therapy outside the study or continue study medication for up to 120 days.] [AS PER AMENDMENT 3/5/98: Patients with virologic failure at Week 16 now proceed to Step III.] Patients without virologic failure continue therapy during Weeks 1 to 48 [AS PER AMENDMENT 3/5/98: and those without virologic failure at Week 48 may continue therapy during Weeks 49 to 96 (first extension study)]. [AS PER AMENDMENT 5/27/99: After Week 96, patients in Arm I may switch to Arm III or seek the best available antiretroviral therapy outside the study. Patients in Arm II or III with undetectable plasma HIV RNA levels at Week 96 may continue therapy during Weeks 97 to 144 (second extension study) or seek the best alternative antiretroviral therapy. Patients in Arm II or III with detectable plasma HIV RNA levels but without virologic failure at Week 48 continue their current study therapy or proceed to Step III. Patients with confirmed virologic failure at Week 48 or later proceed to Step III or seek the best available alternative therapy outside the study.] Group B: Patients receive treatment on their assigned, open-label ACTG 302/303 regimen. Patients with detectable plasma HIV RNA levels discontinue Group B therapy and proceed to Step II. Patients with undetectable plasma HIV RNA levels continue therapy during Weeks 1 to 48 [AS PER AMENDMENT 6/24/98: and those with undetectable levels at Week 48 may continue therapy during Weeks 49 to 96 (first extension study)]. [AS PER AMENDMENT 5/27/99: Patients with undetectable levels at Week 96 may continue therapy during Weeks 97 to 144 (second extension study).] Step II: Patients receive treatment as in Group A. [Step III: AS PER AMENDMENT 3/5/98: Patients choose 1 of 3 alternative therapies: saquinavir soft gel capsule, ritonavir, adefovir dipivoxil, and L-carnitine on Arm X; EFV or NFV plus 2 new approved antiretroviral drugs outside the study on Arm Y (if no prior EFV or NFV); or best available medication outside the study on Arm Z. Patients in Arm X or Y are followed on salvage therapy for 24 to 48 weeks. Patients with detectable plasma HIV RNA levels after 16 weeks on salvage therapy are encouraged to discontinue study medication and seek best alternative treatment.]
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients who have a CD4 count of 200 cells/mm3 or less. Allowed: - Topical and oral antifungal except for oral ketoconazole. - Treatment, maintenance, or chemoprophylaxis with approved agents for opportunistic infections as clinically indicated. - All antibiotics as clinically indicated. - Systemic corticosteroid use for no more than 21 days for acute problems as medically indicated. Note: Steroid use for more than 21 days is considered on a case-by-case basis. - Recombinant erythropoietin (rEPO) and granulocyte colony-stimulating factor (G-CSF) as medically indicated. - Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate, testosterone, or any other medications as medically indicated. [AS PER AMENDMENT 4/25/00: Allowed with caution: - Pentamidine, allopurinol, hydroxyurea. Use of these medications may increase exposure to ddI.] Concurrent Treatment: Allowed: - Dependency of less than 3 units of blood per 21-day period. - Alternative therapies such as acupuncture and visualization techniques. Patients must have: - HIV infection documented by a licensed ELISA and confirmed by Western blot, positive HIV culture, positive HIV antigen, positive plasma HIV RNA, or second antibody test positive by a method other than ELISA. Repeat HIV-antibody testing is not required for enrollment in this trial (implicit in patients having been enrolled in ACTG 302/303). - Signed, informed consent from parent or legal guardian for patients under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Inability to tolerate ddI at 200-400 mg/day, 3TC at 300 mg/day, or d4T at 60-80 mg/day, with intolerance defined as recurrent toxicities requiring dose interruptions and reductions or permanent discontinuation of the drugs (other than Grade 3 or 4 anemia). - Grade 2 or higher peripheral neuropathy. - Malignancy requiring systemic therapy. - Co-enrollment in other antiretroviral protocols; co-enrollment in other ACTG protocols is encouraged, particularly those involving prophylaxis for opportunistic infections. Concurrent Medication: Excluded: - All antiretroviral therapies other than study medications. - Investigational drugs and vaccines without specific approval from the Protocol Chair/Vice Chairs. - Systemic cytotoxic chemotherapy. - Interferon, interleukins, GM-CSF, and HIV-1 vaccines. - Rifabutin and rifampin. - Ketoconazole, astemizole, cisapride, midazolam, terfenadine, and triazolam. - Acute therapy for an infection or other medical illness. - Herbal medications. - Vitamins. [10. AS PER AMENDMENT 3/5/98: - Ergot alkaloids or drugs containing derivatives or ergot alkaloids.] Patients with the following prior conditions are excluded: - History of acute or chronic pancreatitis. Prior Medication: Excluded: - PIs. - NNRTIs. - Acute therapy for an infection or other medical illness within 14 days prior to the time of study entry. - Chronic long-term steroid use is not permitted unless it is within physiologic replacement levels; protocol chair/vice chairs must be contacted in these instances. Risk Behavior: Excluded: - Current ethanol abuse by personal history or a report from a primary physician.
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
MaryAlbrecht, Study Chair,
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112
United States
Michigan State Univ Hemophilia Comprehensive Care Clinic
Lansing, Michigan, 48912
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts
Lebanon, New Hampshire, 03756
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Northwest Ohio Hemo Treatment Ctr / Great Lakes Hemo Fdn
Toledo, Ohio, 43606
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, 20037
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York City, New York, 10029
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225
United States
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp
Green Bay, Wisconsin, 54301
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 532130127
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: ACTG 364;
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001087
Other Hiv Infections Studies:
1. A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
2. Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients
3. A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
4. Preventing Sexual Transmission of HIV With Anti-HIV Drugs
5. Antiviral Activity of and Resistance to Lamivudine in Combination with Zidovudine, Stavudine, or Didanosine
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined with Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
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