|
Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen Clinical research trials and Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen. Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen  Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir (NFV) or efavirenz (EFV) with indinavir/lamivudine/zidovudine (IDV/3TC/ZDV) vs IDV/3TC/ZDV alone, in the treatment of patients with advanced HIV disease who have received limited or no prior antiretroviral therapy. Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of RNA replication and alterations in resistance patterns. Due to the progressive success of combination regimens, it is possible that more potent regimens will further enhance viral suppression and provide more durable treatment responses. In light of the additive suppression of HIV replication determined by pharmacological, immunological, and virological results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will also be evaluated as an addition to IDV/ZDV/3TC.
Details: Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of RNA replication and alterations in resistance patterns. Due to the progressive success of combination regimens, it is possible that more potent regimens will further enhance viral suppression and provide more durable treatment responses. In light of the additive suppression of HIV replication determined by pharmacological, immunological, and virological results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will also be evaluated as an addition to IDV/ZDV/3TC. Patients with HIV infection, CD4 cell count less than or equal to 200 cells/mm3 or plasma HIV RNA greater than or equal to 100,000 copies/ml, and limited (no prior 3TC, NNRTI, or protease inhibitor) or no prior antiretroviral treatment are randomized to 1 of 3 arms. Patients are stratified by CD4 cell count (less than or equal to 50 cells/mm3 vs greater than 50 cells/mm3), HIV-1 RNA copy number (less than or equal to 40,000 copies/ml vs greater than 40,000 copies/ml), and prior antiretroviral therapy (no therapy vs any therapy), and then randomly assigned to 1 of 3 treatment arms: Arm 1: 3TC plus ZDV plus IDV. Arm 2: 3TC plus ZDV plus IDV plus EFV. Arm 3: 3TC plus ZDV plus IDV plus NFV. Patients are followed for at least 72 weeks [AS PER AMENDMENT 2/16/99: 96 weeks] beyond the enrollment of the last patient. Patients who experience virologic relapse will have the option of continuing randomized study medications, switching to Step 2 treatment, switching to another ACTG study, or seeking best available therapy for the remaining weeks of the study. Step 2 treatment consists of abacavir or 2 NNRTIs plus efavirenz plus amprenavir or another protease inhibitor. [AS PER AMENDMENT 4/3/00: Optimally, Step 2 treatment regimens should contain 3 or 4 drugs to which the virus is susceptible. If this is not possible, a drug to which the virus is partially susceptible is acceptable, but a drug to which the virus is resistant should not be included.]
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Chemoprophylaxis for Pneumocystis carinii pneumonia. - Topical and oral antifungal agents (except for oral ketoconazole and itraconazole). - All antibiotics as clinically indicated (unless otherwise excluded). - Treatment, maintenance, or chemoprophylaxis with approved agents for opportunistic infections as clinically indicated (unless otherwise excluded). - 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, megestrol acetate, testosterone. - Alternative therapies such as vitamins. Patients should report the use of these therapies. - [AS PER AMENDMENT 2/16/99: Rifabutin can be administered at a reduced dose.] - [AS PER AMENDMENT 4/3/00: Systemic cytotoxic chemotherapy. Study team should be notified.] - [AS PER AMENDMENT 4/3/00: Expanded access and compassionate use drugs are allowed as part of Step 2 treatment only.] Allowed with caution: - [AS PER AMENDMENT 4/3/00: Viagra (sildenafil citrate) at a reduced dose unless otherwise approved by the protocol chair.] - [AS PER AMENDMENT 4/3/00: Lovastatin or simvastatin with PIs is not recommended. Caution should be exercised with the use of all other statins when used concomitantly with PIs.] Concurrent Treatment: Allowed: - Alternative therapies such as acupuncture and visualization techniques. Patients should report use of these therapies. Patients must have: - Documented HIV-1 infection. - CD4 count less than or equal to 200 cells/mm3 or a plasma HIV RNA greater than or equal to 100,000 copies/ml [AS PER AMENDMENT 2/16/99: - 80,000 copies/ml] within 60 days prior to entry. - Other lab values performed within 14 days prior to entry. Prior Medication: Allowed: - Zidovudine (ZDV), didanosine (ddI), stavudine (d4T), or zalcitabine (ddC) therapy alone or in combination any time prior to study entry. Exclusion Criteria Concurrent Medication: Excluded: - All antiretroviral therapies other than study medications. [AS PER AMENDMENT 4/3/00: Compassionate use and expanded access drugs are allowed as part of Step 2 treatment.] - Investigational drugs without specific approval from the Study Chair. [AS PER AMENDMENT 4/3/00: Compassionate use and expanded access drugs are allowed as part of Step 2 treatment.] - Systemic cytotoxic chemotherapy. [AS PER AMENDMENT 4/3/00: Systemic cytotoxic chemotherapy is allowed. Study team should be notified.] - Alprazolam, amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, encainide, ergot alkaloids and derivatives of ergot alkaloids, estazolam, flecainide, flurazepam, itraconazole , ketoconazole, meperidine, midazolam, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, rifampin, terfenadine, triazolam, or zolpidem. [AS PER AMENDMENT 2/16/99: Amiodarone, astemizole, cisapride, ergot alkaloids or drugs containing derivatives of ergot alkaloids, itraconazole, midazolam, triazolam, quinidine, rifampin, terfenadine.] [AS PER AMENDMENT 4/3/00: Amiodarone, astemizole, bepridil, cisapride, ergot alkaloids and derivatives of ergot alkaloids, Hypericum perforatum (St. John's wort), itraconazole, midazolam, quinidine, rifampin, terfenadine, triazolam.] - Vitamin E supplements. [AS PER AMENDMENT 4/3/00: Multivitamins containing vitamin E are allowed.] Avoided: - Herbal medications. Patients should report use. Patients with the following prior conditions are excluded: - Acute therapy for an infection or other medical illnesses within 14 days prior to study entry. [AS PER AMENDMENT 2/16/99: Acute therapy for a serious infection or other serious medical illnesses that are potentially life-threatening and require systemic therapy and/or hospitalization within 14 days of study entry.] Prior Medication: Excluded within 30 days prior to entry: - More than 1 day experience with lamivudine (3TC), nonnucleoside reverse transcriptase inhibitor, or protease inhibitor. - Erythropoietin, G-CSF, or GM-CSF. - Interferons, interleukins, HIV vaccines, or any experimental therapy. Excluded within 14 days prior to entry: - Alprazolam (Xanax), amiodarone (Cordarone), astemizole (Hismanal), bepridil (Vascor), bupropion (Wellbutrin, Zyban), cisapride (Propulsid), clorazepate (Tranxene), clozapine (Clozaril), diazepam (Valium), encainide (Enkaid), ergot alkaloids or drugs containing derivatives of ergot alkaloids, estazolam (ProSom), flecainide (Tambocor), flurazepam (Dalmane), itraconazole (Sporanox), ketoconazole (Nizoral), meperidine (Demerol), midazolam (Versed), piroxicam (Feldene), propafenone (Rythmol), propoxyphene (Darvon, Darvocet), quinidine, rifabutin (Mycobutin), rifampin (Rifadin, Rifamate, Rifater, Rimactane), terfenadine (Seldane), triazolam (Halcion), or zolpidem (Ambien). [AS PER AMENDMENT 2/16/99: Agents excluded within 14 days prior to entry are now as follows: - amiodarone, astemizole, cisapride, ergot alkaloids or drugs containing derivatives of ergot alkaloids, itraconazole, midazolam, quinidine, rifampin, terfenadine, and triazolam. Note: - Rifabutin can be administered at a reduced dose of 150 mg/day.]
Total Enrollment: 501
Location and Contact Information:
Overall Study Official:
MargaretFischl, Study Chair,
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Chelsea Ctr
New York City, New York, 10021
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Univ of Washington
Seattle, Washington, 981224304
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Kaiser Permanente LAMC
Los Angeles, California, 90027
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Spedali Civili - Carosi
Brescia, ,
Italy
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Willow Clinic
Menlo Park, California, 94025
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, 20037
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
VA Hosp at San Diego / Pediatrics
San Diego, California, 92161
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Emory Univ
Atlanta, Georgia, 30308
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Additional Information:
Study ID Numbers: ACTG 388; Substudy ACTG 734,Substudy ACTG A5060s,Substudy ACTG 732,Substudy ACTG 733,Substudy ACTG 735,Substudy ACTG 737,Substudy ACTG 746
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000903
Other Hiv Infections Studies:
1. A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
2. A Randomized Trial of the Efficacy and Safety of a Strategy of Starting with Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals with CD4+ Cell Counts Less than or Equal to 200/mm3
3. A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients
4. Longitudinal Study of Ocular Complications of AIDS (LSOCA)
5. A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects with HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other Hawaii Clinical Trials
Other Honolulu Clinical Trials
Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
|
|
|
|
|
|
|
|
