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A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection Clinical research trials and A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection. A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection clinical trial. Human subjects often obtain the finest healthcare possible for their A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection  A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection
A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to compare the effectiveness of various combinations of anti-HIV drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV). Anti-HIV therapy is effective in preventing the spread of HIV in the body. However, patients often experience unpleasant side effects and have difficulties following the dosing schedule. This study looks for combinations of anti-HIV drugs ("cocktails") which will be the most effective with the fewest problems.
Details: Highly active antiretroviral therapy, though effective in the suppression of HIV proliferation, is often complicated by difficulties with adherence and drug toxicity. Various combinations of highly active antiretroviral therapy exist; all have proved efficacious in related trials. The question addressed in this trial is which combination of antiretroviral "cocktails" provides the single greatest advantage in preventing the spread of HIV in the body. In effect, which therapy provides the greatest benefit with the fewest complications. Step 1: Patients are randomized to 1 of 6 arms: Arm A: didanosine (ddI), stavudine (d4T), efavirenz (EFV), and nelfinavir (NFV) placebo. Arm B: ddI, d4T, EFV placebo, and NFV. Arm C: lamivudine (3TC)/zidovudine (ZDV), EFV, and NFV placebo. Arm D: 3TC/ZDV, EFV placebo, and NFV. Arm E: ddI, d4T, EFV, and NFV. Arm F: 3TC/ZDV, EFV, and NFV. Patients with virologic failure on 2 successive measurements or study-drug intolerance discontinue their randomized study therapy and proceed to Step 2. [AS PER AMENDMENT 7/5/00: Patients must switch regimens as soon as possible after confirmation of virologic failure to prevent development of drug resistance.] Step 2: Arm A: Patients receive treatment as in Arm D of Step 1. Arm B: Patients receive treatment as in Arm C of Step 1. Arm C: Patients receive treatment as in Arm B of Step 1. Arm D: Patients receive treatment as in Arm A of Step 1. Arms A, B, C, and D: Patients who fail Step 2 treatment proceed to Step 3. Arms E and F: Patients with virologic failure on Step 1 proceed immediately to Step 3. Step 3 (salvage therapy): Arm A, B, C, and D: Patients receive indinavir (IDV), amprenavir (APV), ddI, and hydroxyurea (HU). [AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 1, 2, 3, 4, 5, or 6. Regimen 1 consists of IDV, ritonavir (RTV), ddI, and HU. Regimen 2 consists of APV, RTV, ddI, and HU. Regimen 3 consists of IDV, RTV, abacavir (ABC), and 3TC/ZDV. Regimen 4 consists of APV, RTV, ABC, and 3TC/ZDV. Regimen 5 consists of IDV, RTV, ABC, d4T, and 3TC. Regimen 6 consists of APV, RTV, ABC, d4T, and 3TC.] Arm E: Patients receive IDV, APV, and 3TC/ZDV. [AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 7 or 8. Regimen 7 consists of IDV, RTV, and 3TC/ZDV. Regimen 8 consists of APV, RTV, and 3TC/ZDV.] Arm F: Patients receive IDV, APV, ddI, and d4T. [AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 9 or 10. Regimen 9 consists of IDV, RTV, ddI, and d4T. Regimen 10 consists of APV, RTV, ddI, and d4T.] [AS PER AMENDMENT 7/5/00: Patients already enrolled in Step 3 before site registration to Version 4.0 of this protocol have the option of receiving 1 of the appropriate new Step 3 regimens as outlined above or staying on their originally assigned Step 3 therapy.] [AS PER AMENDMENT 3/21/01: If virologic failure on Step 1 or 2 is confirmed, then HIV-1 RNA genotype resistance testing (in real-time, if possible) is performed. Patients receive 1 of the Step 3 drug regimens based on the results of the resistance testing.] Patients may co-enroll in metabolic, pharmacologic, immunologic, or adherence substudies.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: [Required: AS PER AMENDMENT 7/5/00: - Chemoprophylaxis for Pneumocystis carinii pneumonia if CD4+ cell count is less than or equal to 200 cells/mm3.] [Suggested as an alternative agent for chemoprophylaxis against Mycobacterium avium complex: - Azithromycin.] [Allowed: AS PER AMENDMENT 7/5/00: - Topical and oral antifungal agents. Oral itraconazole may be administered concurrently with IDV if the dose of IDV is reduced to 600 mg every 8 hours. - Treatment, maintenance, or chemoprophylaxis for opportunistic infections, as clinically indicated unless otherwise prohibited by the protocol. - All antibiotics, as clinically indicated unless otherwise prohibited by the protocol. - Systemic corticosteroid use for 21 days or less for acute problems, as medically indicated. - Recombinant erythropoietin (rEPO, epoetin alfa, Epogen, epoetin beta, Marogen), granulocyte colony-stimulating factor (G-CSF, filgrastim, Neupogen), and granulocyte-macrophage colony-stimulating factor (GM-CSF, Regramostim). - Regularly prescribed medications, such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate (Megace), testosterone, or any other medications, as medically indicated unless otherwise prohibited by the protocol. NOTE: Due to the possibility that study medications may alter the effectiveness of oral contraceptives or depoprogesterone, these agents must not be used as the sole form of birth control, because the role of some study medications on the effectiveness of these methods has not yet been established. - Alternative therapies, such as vitamins. - Medications requiring low gastric pH if not administered at the same time as buffered ddI. Patients taking these agents should do so at least 2 hours before ddI.] - Vaccinations, if administered at least 2 weeks prior to an HIV RNA viral load evaluation. [Allowed with caution: AS PER AMENDMENT 7/5/00: - Oral ketoconazole with IDV. Medications that interact with PIs as substrates, inhibitors, or inducers, including, but not limited to: - allopurinol, alprazolam, amitriptyline, atorvastatin, bupropion, carbamazepine, cerivastatin, chlorpheniramine, chlorpromazine, chlorzoxazone, cimetidine, clarithromycin, clofibrate, clorazepate, clozapine, codeine, dapsone, desipramine, diazepam, diltiazem, disopyramide, encainide, erythromycin, estazolam, estrogens and progesterones, fluoxetine, flurazepam, fluvastatin, glucocorticoids, hypericum perforatum (St. John's wort), imipramine, isoniazid, itraconazole, ketoconazole, labetalol, lamotrigine, lidocaine, lovastatin, mexiletine, morphine, naloxone, nefazodone, nifedipine, nortriptyline, opioids, oxazepam, pentazocine, phenobarbital, phenytoin, promethazine, propofol, propranolol and other beta blockers, sildenafil, simvastatin, temazepam, T3 (thyroid hormone), warfarin, valproic acid, and zolpidem. - Drugs with high protein-binding properties, nephrotoxic drugs, and opiate agonists (e.g., methadone or buprenorphine).] NOTE: - Refer to package insert for potential drug interactions with IDV, RTV, NFV, or APV that may require therapeutic drug monitoring and/or adjustment of concomitant medications.] [Allowed with extreme caution: - AS PER AMENDMENT 7/5/00: ddI, as clinically indicated in patients with known risk factors, including, but not limited to, alcohol abuse, morbid obesity, hypertriglyceridemia, cholelithiasis, endoscopic retrograde cholangiopancreatography, use of medications known to cause pancreatitis (e.g., pentamidine) and use of medications known or thought to increase exposure to ddI (e.g., HU, allopurinol).] Concurrent Treatment: [Allowed: - AS PER AMENDMENT 7/5/00: Acupuncture and visualization techniques.] Patients must have: - HIV infection, as documented by any licensed ELISA test kit and confirmed by either 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. - Plasma HIV-1 RNA of 500 copies/ml or more, confirmed by the Roche Amplicor assay only and performed within 60 days [AS PER AMENDMENT 5/5/99: - 70 days] of study entry by any certified laboratory. - Inclusion laboratory parameters, documented within 14 days prior to study entry (see lab values). [AS PER AMENDMENT 9/9/99: - Co-enrollment on ACTG A5005s (Metabolism Substudy) is required for patients enrolling under Version 3.0 of ACTG 384.] Risk Behavior: [Allowed with caution: - AS PER AMENDMENT 7/5/00: Alcoholic beverages.] Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: AIDS-related malignancy other than minimal Kaposi's sarcoma. Concurrent Medication: [Excluded: - AS PER AMENDMENT 7/5/00: - Chronic systemic corticosteroids. - For Steps 1 and 2, all antiretroviral therapies other than study medications. For step 3, contact the team to discuss potential addition or substitution with off-study antiretroviral medications. - Investigational drugs without specific approval from the study chairs. - Neurotoxic and pancreatotoxic drugs. - Systemic cytotoxic chemotherapy. - Amiodarone, astemizole, bepridil, cisapride, cholestyramine, ergot and ergot derivatives, flecainide, ganciclovir, interferon alfa, midazolam (unless used for sedation on ACTG 723), pimozide, propafenone, propoxyphene, quinidine, ribavirin, rifampin, sucralfate, terfenadine, and triazolam. - Rifabutin for patients on RTV in Step 3 and for patients on Steps 1 and 2 because of the contradictory effects of EFV and NFV on plasma rifabutin levels. If a patient on Step 1 or 2 requires treatment with rifabutin after coming on the study, the team must be notified. - Alpha tocopherol (vitamin E) supplementation since vitamin E is contained in the soft gelatin capsule formulation of APV. - ddI concurrently with IV pentamidine. - Herbal medications.] Patients with the following prior conditions are excluded: - Pancreatitis within 3 years of study entry. - Current peripheral neuropathy grade 2 or greater or history of peripheral neuropathy grade 3 or greater. - Documented or suspected acute hepatitis within 30 days prior to study entry. - Unexplained temperature above 38.5 C for any 7 days or chronic diarrhea (defined as more than 3 liquid stools per day persisting for more than 15 days) within 30 days prior to study entry. - Any previous hypersensitivity to study drugs or their components. Prior Medication: Excluded: - Receipt within 30 days of erythropoietin, G-CSF, or GM-CSF. - Treatment within 14 days of study entry with any of the following: - amiodarone, astemizole, cisapride, ergot or ergot derivatives, ketoconazole, midazolam, propoxyphene, quinidine, rifampin, terfenidine, or triazolam. - Prior antiretroviral therapy for 7 days or more, including protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), and nonnucleoside reverse transcriptase inhibitors (NNRTIs). [AS PER AMENDMENT 5/5/99: - Systemic ketoconazole or itraconazole, intravenous pentamidine, and rifabutin are prohibited. Midazolam is allowed for sedation in patients participating on ACTG 723.] - Any vaccination within 14 days prior to study entry. - Any immunomodulator or investigational therapy within 30 days prior to study entry. [AS PER AMENDMENT 5/5/99: - 6. Rifabutin is discouraged.] Prior Treatment: Excluded: - Acute therapy for an infection or other medical illness within 14 days prior to study entry. [AS PER AMENDMENT 5/5/99: - Acute therapy for a serious infection or other serious medical illness that is potentially life-threatening and requires systemic therapy and/or hospitalization within 14 days of study entry. Patients with Pneumocystis carinii pneumonia must have completed acute therapy at least 7 days prior to entry and be clinically stable. Patients with other serious infection or serious medical illness who must continue chronic therapy must have completed at least 14 days of therapy prior to entry and be clinically stable. Patients with all other infections or medical illnesses must have completed therapy, or at least 14 days of maintenance therapy, prior to entry and be clinically stable (restrictions do not apply to oral and vaginal candidiasis, mucocutaneous herpes simplex infection, and minor skin conditions).] Risk Behavior: Excluded: - Possible current substance abuse that could prevent compliance with the study medication.
Total Enrollment: 900
Location and Contact Information:
Overall Study Official:
RobertShafer, Study Chair,
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Archispedale S Maria Nuova
Reggio Emilia, ,
Italy
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Azienda USL di Piacenza
Unknown, ,
Italy
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Washington
Seattle, Washington, 98104
United States
IRCCS Policlinico S Matteo Filice
Pavia, ,
Italy
Cook County Hosp
Chicago, Illinois, 60612
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Universita di Roma - Delia
Roma, ,
Italy
Archispedale S Anna
Ferrara, ,
Italy
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Ospedale Luigi Sacco Cargnel
Milano, ,
Italy
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
IRCCS Policlinico S Matteo Minoli
Pavia, ,
Italy
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Spedali Civili Cadeo
Brescia, ,
Italy
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Akron City Hospital
Akron, Ohio, 44304
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Azienda Ospedaliera di Parma
Parma, ,
Italy
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Ospedale Civile Maggiore
Verona, ,
Italy
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Spedali Civili - Carosi
Brescia, ,
Italy
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, 15213
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112
United States
Francesco Leoncini
Unknown, ,
Italy
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Marin County Specialty Clinic
San Rafael, California, 94903
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Azienda Ospedaliera Umberto I
Ancona, ,
Italy
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Ospedale S Orsola
Bologna, ,
Italy
Universita di Genova
Genova, ,
Italy
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Manhattan Veterans Administration / New York Univ Med Ctr
New York City, New York, 10016
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, 20037
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Willow Clinic
Menlo Park, California, 94025
United States
Ospedale Luigi Cacco Moroni
Milano, ,
Italy
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Chelsea Ctr
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: ACTG 384; AACTG A5005s,AACTG A5006s,AACTG A5007s,AACTG A5031s,AACTG 731
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000919
Other Hiv Infections Studies:
1. An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3)
2. A Study of Zidovudine in the Prevention of HIV Infection in Individuals Exposed to the Virus
3. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
4. A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
5. Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Milano Clinical Trials
A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection
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