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A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients Clinical research trials and A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients. A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients clinical trial. Human subjects often get the best healthcare possible for their A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients  A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients
A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To compare the proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels [AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive assay] among the 3 regimens during the maintenance phase. The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic function and delay the development of HIV-related complications. In patients administered potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and below the level of detection of commercially available assays. This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen. The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens.
Details: The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic function and delay the development of HIV-related complications. In patients administered potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and below the level of detection of commercially available assays. This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen. The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens. All patients will receive open label induction therapy with zidovudine (ZDV), lamivudine (3TC) and indinavir (IDV) for 6 months. Following the 6 month induction phase, patients with undetectable plasma HIV RNA at weeks 16, 20 and 24 will enter the maintenance phase [blinded maintenance phase AS PER AMENDMENT 09/19/97] and be randomized to one of three maintenance regimens, i.e., either continued ZDV/3TC/IDV (control), or ZDV/3TC/IDV placebo or ZDV placebo/3TC placebo/IDV. Prior to randomization, patients are stratified according to entry HIV RNA level (greater than or equal to 30,000 or less than 30,000 copies/ml) and by prior ZDV therapy (at least 7 days or less than 7 days). After 12 months [AS PER AMENDMENT 09/19/97: 18 months] of maintenance therapy, treatment will be withdrawn at 6-month intervals in randomly-selected patients who have achieved undetectable HIV RNA. AS PER 09/19/97 AMENDMENT: After 18 months of blinded maintenance therapy, treatment is unblinded for patients whose HIV RNA levels remain detectable. Such patients receive optimal therapy, either continuing the protocol regimen or initiating alternative therapy. AS PER AMENDMENT 2/27/98: An interim review conducted in January, 1998 demonstrated that the strategy of less intensive antiviral therapy after 6 months of IDV/3TC/ZDV induction therapy is less effective than continuation of triple drug therapy except for ZDV-naive patients assigned to ZDV/3TC. Therefore, the maintenance phase of this study has been discontinued. Patients currently on blinded maintenance are unblinded immediately and have the option of reinitiating open-label triple therapy with IDV/3TC/ZDV or discontinuing study treatment. Patients currently on induction may register for continued open-label triple therapy or may discontinue study treatment. This amendment allows treatment extension so that subjects may receive open-label triple therapy until May 31, 1998. At that time, a rollover protocol or another modification with a longer period of drug supply may become available. Patients who choose to go off treatment are followed until May 31, 1998. AS PER AMENDMENT 04/23/98: This study will now provide treatment with open-label ZDV/3TC/IDV until August 1, 1998. A rollover protocol or another 343 protocol modification with a longer period of drug supply may become available, but this cannot be guaranteed. AS PER AMENDMENT 06/19/98: This study will now provide treatment with open-label ZDV/3TC/IDV until either November 1, 1998 or until 3 months after the rollover study (A5025) is available to the study sites (whichever comes first).
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - A CD4 cell count >= 200 cells/mm3 within 90 days prior to study entry. - Plasma HIV RNA >= 1000 copies/ml within 90 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: - A malignancy that requires systemic chemotherapy. Concurrent Medication: Excluded: - Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed). - All antiretroviral therapies other than study medications. - Rifabutin and rifampin. - Investigational drugs and vaccines. - Systemic cytotoxic chemotherapy. - Interferon, interleukins, GM-CSF and HIV vaccines. Patients with any of the following prior conditions are excluded: - Unexplained temperature > 38.5 degrees C for any 7 days within 30 days prior to study entry. - Chronic diarrhea as defined as > 3 liquid stools per day persisting for 15 days within 30 days prior to study entry. - Proven or suspected acute hepatitis within 30 days prior to study entry, even if AST and ALT are <= 5.0 X ULN (upper limit of normal). - A history of >= Grade 2 bilateral peripheral neuropathy within 60 days prior to study entry. - A history of intolerance to 300 mg/day of ZDV defined as any toxicity requiring a dose reduction or termination of ZDV. Prior Medication: Excluded: - Acute therapy for an infection or other medical illness within 14 days prior to study entry. - Any prior therapy with 3TC or experimental drug 1592. - More than 2 weeks of lifetime exposure to protease inhibitor therapy; any exposure within 14 days prior to study entry. - Interferons, interleukins, GM-CSF or HIV vaccines within 30 days prior to study entry. - Any experimental therapy (drugs or vaccines) within 30 days prior to study entry. - Rifampin or rifabutin within 14 days prior to study entry. - Systemic cytotoxic chemotherapy within 30 days prior to study entry. - Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed).
Total Enrollment: 500
Location and Contact Information:
Overall Study Official:
HavlirD, Study Chair,
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Additional Information:
Study ID Numbers: ACTG 343;
Study Start Date:
Record last reviewed: April 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001084
Other Hiv Infections Studies:
1. A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides
2. A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements
3. An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients with Progressive HIV Disease
4. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
5. A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
Related Studies:
Other HIV Infections Clinical Trials
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Other New York City Clinical Trials
A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients
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