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Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients 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 Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients Clinical research trials and Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients 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 Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients. Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients 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 Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients clinical trial. Human subjects often obtain the finest healthcare possible for their Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients 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 > "E" Clinical Trials Conditions > Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients  Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
For Condition: HIV Infections
Status: Suspended
Sponsor(s): Agouron Pharmaceuticals ,
Synopsis: The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.
Details: [Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.] Patients are randomized to receive Viracept plus Combivir plus either AG1549 or placebo. Patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit. Blood samples are taken regularly to quantify plasma HIV-1 RNA, CD4 and CD8 counts, and peripheral blood mononuclear cells (PBMC). Physical exams, safety assessments, and other tests are also done throughout the study. A blood sample is taken at baseline (pre-dose) for a pharmacokinetics assessment. On Day 8 and at the end of Weeks 4, 8, 16, 24, 36, and 48, pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible if they: - Are HIV-positive. - Are at least 18 years old. - Have a CD4 cell count of more than 50 cells/mm3. - Have an HIV level of more than 5000 copies/ml. Exclusion Criteria Patients will not be eligible if they: - Have ever taken any of the following anti-HIV drugs: nonnucleoside reverse transcriptase inhibitors (NNRTIs), AG1549, Viracept, zidovudine, lamivudine, or Combivir. Other anti-HIV drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry. - Have taken an experimental drug within 28 days of study entry.
Total Enrollment: 350
Location and Contact Information:
Research & Treatment at the California Pacific Med Ctr
San Francisco, California, 94114
United States
Univ of Med & Dentistry of New Jersey
Newark, New Jersey, 07103
United States
Northwestern Univ Med Ctr
Chicago, Illinois, 60611
United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
United States
Larry Bush
Palm Springs, Florida, 33461
United States
University of Louisville / ID Division
Louisville, Kentucky, 40202
United States
Univ of Puerto Rico School of Med
Rio Piedras, , 00935
Puerto Rico
South Shore Hosp
Miami, Florida, 33139
United States
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
United States
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, 70112
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Sky Blue
Boise, Idaho, 83704
United States
Paul Alessi
Cherry Hill, New Jersey, 08034
United States
St Mary's Hosp Family Treatment Ctr
Hoboken, New Jersey, 07030
United States
Univ of Southern California
Los Angeles, California, 90033
United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111
United States
Sunnybrook Health Science Centre
Toronto, Ontario,
Canada
QEII Health Science Centre
Halifax, Nova Scotia,
Canada
Polk County Health Dept
Winter Haven, Florida, 33881
United States
Canadian HIV Trials Network
Vancouver, British Columbia,
Canada
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
United States
Bach and Godofsky
Bradenton, Florida, 34205
United States
Univ of Iowa
Iowa City, Iowa, 52242
United States
Community Health Care
Ft. Lauderdale, Florida, 33306
United States
Montreal Chest Institute
Montreal, Quebec,
Canada
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, 53203
United States
Bentley-Salick Medical Practice PC
New York City, New York, 10003
United States
Univ of Florida
Jacksonville, Florida, 32209
United States
Immunity Care and Research Inc
Santo Domingo, ,
Dominican Republic
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Harbor - UCLA Med Ctr
Torrance, California, 90502
United States
Infectious Diseases Associates
Sarasota, Florida, 34239
United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77555
United States
Univ of Nebraska Medical Ctr
Omaha, Nebraska, 681985400
United States
Infectious Disease Research Institute
Tampa, Florida, 33614
United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 452670405
United States
Orange County Health Dept
Orlando, Florida, 32805
United States
ViRx Inc
Palm Springs, California, 92262
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018
United States
Joseph C Gathe
Houston, Texas, 77004
United States
Med Univ of South Carolina
Charleston, South Carolina, 29425
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Thomas Street Clinic
Houston, Texas, 77009
United States
Hawthorne Med Associates / PAACA
New Bedford, Massachusetts, 02745
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
United States
Clinical Research Puerto Rico Inc
San Juan, , 009091711
Puerto Rico
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Southwest Infectious Diseases Associates
Dallas, Texas, 75246
United States
Additional Information:
Study ID Numbers: 286C; AG1549-504
Study Start Date: August 1999
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004999
Other Hiv Infections Studies:
1. A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
2. A Study of Patients with AIDS Syndrome
3. A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
4. Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant
5. Study of Women Who Have AIDS
Related Studies:
Other HIV Infections Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
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