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Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320 Clinical research trials and Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320 medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320. Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320 Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320 clinical trial. Participants frequently obtain the most expert healthcare available for their Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320 condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320  Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320
Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Group A: To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To compare the time to confirmed treatment failure, permanent discontinuation of treatment, or death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.] Group B: To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500 copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms. Group C: To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients treated with ZDV or stavudine (d4T) plus 3TC and IDV. Group D: To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV. This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable. This study will examine the question of whether intensification of therapy can prolong the virologic benefit in individuals whose plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T) plus 3TC plus IDV.]
Details: This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is included. This study will examine the question of whether intensification of therapy can prolong the virologic benefit in individuals whose plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T) plus 3TC plus IDV.] Rollover patients from ACTG 320 are given enrollment priority and permitted to enroll in all 4 study groups; non-ACTG patients are permitted to enroll in Groups A and B if accrual objectives are not met with ACTG 320 patients. GROUP A: Patients with screening plasma HIV-1 RNA concentrations below 500 copies/ml are randomized to 1 of 2 treatment arms and stratified according to their participation in ACTG 320 (original randomization to IDV versus open-label IDV). The 2 treatment arms are as follows: ARM A1: IDV plus ZDV (or d4T) plus 3TC plus ABC. ARM A2: IDV plus ZDV (or d4T) plus 3TC plus ABC placebo. Patients who achieve a plasma HIV-1 RNA level of 500 copies/ml or more on 2 consecutive determinations may continue their assigned arm in a blinded fashion, or seek the best alternative therapy selected by the local investigator or primary care physician. GROUP B: Nonnucleoside reverse transcriptase inhibitor (NNRTI)-naive patients with plasma HIV-1 RNA plasma concentrations of 500 copies/ml or more are randomized to 1 of 4 treatment arms and stratified by plasma HIV-1 RNA concentrations (above versus below 15,000 RNA copies/ml) and participation in ACTG 320 (original randomization to IDV versus open-label IDV). The treatment arms are as follows: ARM B1: ABC plus EFV plus adefovir dipivoxil plus NFV. ARM B2: ABC plus EFV plus adefovir dipivoxil plus NFV placebo. ARM B3: 2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 if 2 not tolerated) (chosen from ZDV, 3TC, d4T, or didanosine [ddI]) plus EFV plus adefovir dipivoxil plus NFV. ARM B4: 2 NRTIs (or 1 if 2 not tolerated) (chosen from ZDV, 3TC, d4T, or ddI) plus EFV plus adefovir dipivoxil plus NFV placebo. GROUP C: NNRTI-naive patients with plasma HIV-1 RNA concentrations of 500-2,000 copies/ml at screening may elect to be randomized to a treatment arm in Group B or continue with their current ACTG 320 regimen as follows: ARM C: ZDV (or d4T) plus 3TC plus IDV. Patients who elect this treatment are randomized in Group B if their plasma HIV-1 RNA concentrations are confirmed to be above 2,000 copies. GROUP D: NNRTI-experienced, ACTG 320 patients with screening plasma HIV-1 RNA concentrations of 500 copies/ml or more receive open-label treatment as follows: ARM D: ABC plus EFV plus adefovir dipivoxil plus NFV. [AS PER AMENDMENT 06/29/98: Enrollment to Group B is closed to accrual. Group A patients with HIV-1 RNA of 200 copies/ml or more on 2 consecutive determinations may continue their assigned treatment or seek best alternative antiretroviral therapy, which may include access to ABC. Group B patients with plasma HIV-1 RNA of 500 copies/ml or more may continue their assigned treatment or seek best available antiretroviral therapy, which may include access to ABC, EFV, and adefovir dipivoxil with L-carnitine supplementation. Group C patients with HIV-1 RNA levels above 2,000 copies/ml and Group D patients with levels above 500 copies/ml may no longer be randomized to a treatment arm in Group B. Such patients may continue their assigned treatment or seek best available therapy, which may include access to therapy as per Group B patients.] [AS PER AMENDMENT 06/16/99: Study treatment for Groups B, C, and D has been completed. Group A patients with a confirmed plasma HIV-2 endpoint who remain on study may have access to ABC while on study.] [AS PER AMENDMENT 12/27/01: With Version 4.0 of the protocol, many of the metabolic assessments and the cardiovascular risk assessment will be repeated, and a self-reported questionnaire of body shape changes will be added. In addition, an investigation of the effect of long-term IDV on pyuria/hematuria is added, as well as a study of HIV-1 RNA in peripheral blood mononuclear cells (PBMCs).]
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients with a CD4 cell count of 200 cells/mm3 or less. Allowed: - Treatment, maintenance, or chemoprophylaxis, including topical and/or oral antifungal agents unless otherwise excluded by the protocol. - All antibiotics as clinically indicated, unless otherwise excluded in the protocol. - Systemic corticosteroid use for 21 days or less for acute problems as medically indicated. Chronic corticosteroid use is not permitted, unless it is within physiologic replacement levels. Study team must be contacted in these instances. - rEPO and G-CSF as medically indicated. - Regularly prescribed medications such as [AS PER AMENDMENT 06/29/98: alternative, FDA-approved antiretrovirals not supplied by the study] [AS PER AMENDMENT 12/27/01: or unapproved antiretrovirals available by expanded access (when permanently discontinued from randomized study treatment)], antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate, testosterone, or any other medications not otherwise excluded by the protocol, as medically indicated. - [AS PER AMENDMENT 12/27/01: Supplemental and] alternative therapies such as vitamins, acupuncture, and visualization techniques. Recommended as an alternative agent for chemoprophylaxis against Mycobacterium avium complex for patients randomized to EFV in Group B or D: - clarithromycin or azithromycin. Patients must have: - HIV-1 infection as documented by any licensed ELISA test kit and confirmed by either a Western Blot, HIV culture, HIV antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry. Non-ACTG patients: - Documented CD4 cell count of 200 cells/mm3 or less at the time of initiation of ZDV (or d4T) plus 3TC plus IDV. - Signed, informed consent from a parent or legal guardian for patients under 18 years of age. Prior Medication: Required: Non-ACTG 320 patients: - At least 3 months prior therapy with ZDV (or d4T) plus 3TC plus IDV and continued receipt of ZDV (or d4T) plus 3TC plus IDV until enrollment. IDV and 3TC must have been initiated concurrently. ACTG patients: - Randomization to the ZDV (or d4T) plus 3TC plus IDV combination arm or receipt of open-label prior to unblinding and maintenance of that treatment as participation in ACTG 320. Group D: - Prior NNRTI-exposure. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: - Unexplained temperature above 38.5 C for any 7 days or chronic diarrhea, defined as more than 3 liquid stools per day persisting for 15 days, within 30 days prior to study treatment. - AIDS-related malignancy, other than minimal Kaposi's sarcoma that requires systemic chemotherapy. Minimal Kaposi's sarcoma is defined as 5 or fewer cutaneous lesions and no visceral disease or tumor-associated edema that does not require systemic therapy. - Documented or suspected acute hepatitis within 30 days prior to study entry, irrespective of laboratory values. Concurrent Medication: Excluded: - All antiretroviral therapies other than study [AS PER AMENDMENT 06/16/99: provided] medications, [AS PER AMENDMENT 06/16/99: unless approved by the protocol chairs] [AS PER AMENDMENT 12/27/01: while on original randomized treatment.] - Rifabutin and rifampin. - Investigational agents without specific approval from the protocol chair. - Systemic cytotoxic chemotherapy. - Oral ketoconazole and itraconazole. NOTE: Itraconazole may be permitted for Group B and Group D patients if fluconazole is not an option. - Terfenadine, astemizole, cisapride, triazolam, midazolam, amiodarone, quinine, ergot derivatives, isotretinoin, [AS PER AMENDMENT 12/27/01: pimozide, St.John's Wort, and milk thistle.] - [AS PER AMENDMENT 12/27/01: Concomitant use of lovastatin or simvastatin is not recommended because of potential drug interactions. Pravastatin or atorvastatin may be used after consultation with the Study Team.] To be avoided: - Herbal medications. Prior Medication: Excluded: - Any prior protease inhibitor therapy other than indinavir. - Interferons, interleukins, or HIV vaccines within 30 days prior to study entry. - Any experimental therapy within 30 days prior to study entry. - Rifampin, rifabutin, ketoconazole, or itraconazole within 14 days of study entry. Non-ACTG patients: - Acute therapy for an infection or other medical illness within 14 days prior to study therapy. - NNRTI therapy prior to study entry (with the exception of Group D). - Recombinant erythropoietin (rEPO), granulocyte colony-stimulating factor (G-CSF, filgrastim), or granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) within 30 days prior to study entry. Caution should be taken in the consumption of alcoholic beverages with study medications.
Total Enrollment: 440
Location and Contact Information:
Overall Study Official:
ScottHammer, Study Chair,
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York City, New York, 10021
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Chelsea Ctr
New York City, New York, 10021
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, 20037
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Additional Information:
Study ID Numbers: ACTG 372; ACTG 701,ACTG 702,ACTG 706
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000885
Other Hiv Infections Studies:
1. A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole
2. Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis carinii Pneumonia Prophylaxis
3. Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
4. A Study of MKC-442 in HIV-Positive Patients
5. A Registry of Tuberculosis Cases in the CPCRA
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Charlotte Clinical Trials
Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320
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