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A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs 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 Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs Clinical research trials and A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs 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 Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs. A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs 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 Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs clinical trial. Human subjects often obtain the finest healthcare possible for their A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs 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 Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs
A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: The purpose of this study is to compare the effectiveness of treatment with tenofovir DF (TDF) plus lamivudine (3TC) plus efavirenz (EFV) with that of stavudine (d4T) plus 3TC plus EFV in HIV-infected patients who previously have not used anti-HIV drugs.
Details: Patients will be stratified on the basis of HIV-1 RNA levels (greater than 100,000 copies/ml or less than or equal to 100,000 copies/ml) and CD4 count (less than 200 cells/mm3 or greater than or equal to 200 cells/mm3). Treatment-naive patients with HIV-1 RNA levels greater than 5,000 copies/ml will be randomized 1:1 to 1 of 2 treatment arms: Group 1: TDF + d4T placebo + 3TC + EFV Group 2: TDF placebo + d4T + 3TC + EFV TDF/placebo and d4T/placebo will be administered in a blinded fashion. 3TC, EFV, and nevirapine (administered in the event of EFV-associated CNS toxicity) will be administered in open-label fashion. Patients will be monitored for safety using periodic physical examinations, serial laboratory tests, and bone densitometry tests. Additionally, changes in plasma HIV-1 RNA levels and CD4 cell counts will be monitored to assess antiviral efficacy. At the end of Week 48, patients without dose-limiting toxicity will have the option to roll over into open-label extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study. Only open-label tenofovir DF will be provided beyond Week 48.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 18 to 65 years old. - Are HIV-1 positive. - Have HIV-1 RNA levels greater than 5,000 copies/ml within 28 days of screening visit. - Agree to use effective methods of birth control during study and for 30 days after study ends. Exclusion Criteria Patients will not be eligible for this study if they: - Are unable to take medications by mouth. - Have chronic nausea or vomiting. - Have cancer, other than skin cancer. - Have had active, serious infections requiring antibiotic shots within 15 days prior to screening. - Are taking probenecid, systemic corticosteroids, interleukin-2 (IL-2), experimental drugs (unless approved by Gilead Sciences), drugs that are harmful to the kidneys, or drugs that interact with efavirenz. - Are receiving chemotherapy. - Have been diagnosed with an AIDS-defining condition. - Have had significant kidney or bone disease. - Have ever taken certain anti-HIV drugs. - Have had chemotherapy or immunizations within 30 days of beginning of study. - Are pregnant or breast-feeding. - Have a condition which may affect the ability to participate in this study, such as alcohol or substance abuse. - Have received, or expect to receive, treatment for Kaposi's sarcoma.
Total Enrollment: 600
Location and Contact Information:
Jemsek Clinic
Huntersville, North Carolina, 28078
United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
United States
Steinhart Medical Associates
Miami, Florida, 33133
United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
United States
CRI - Springfield
Springfield, Massachusetts, 01107
United States
Inst Dom De Estudios Virologicos
Santa Domingo, ,
Dominican Republic
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Pacific Oaks Med Group
Beverly Hills, California, 90211
United States
San Juan AIDS Program
Santurce, , 00908
Puerto Rico
Mercer University School of Medicine
Macon, Georgia, 31201
United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
United States
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, 27157
United States
Living Hope Clinical Trials
Long Beach, California, 90813
United States
Rockefeller Univ
New York City, New York, 10021
United States
St Vincents Hosp / Clinical Research Program
New York City, New York, 10011
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
Hillsborough County Health Dept
Tampa, Florida, 33602
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Ocean View Internal Medicine
Long Beach, California, 90803
United States
Virginia Commonwealth Univ
Richmond, Virginia, 23298
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Coastal Carolina Research Ctr
Mount Pleasant, South Carolina, 29464
United States
Clinical Research Puerto Rico Inc
San Juan, , 009091711
Puerto Rico
Family Health Care Ctr at SSTAR
Fall River, Massachusetts, 02720
United States
Univ of Texas Med Branch
Galveston, Texas, 775550835
United States
Gary Brewton
Houston, Texas, 77098
United States
South Shore Hosp
Miami, Florida, 33139
United States
Miriam Hosp
Providence, Rhode Island, 02906
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Palm Beach County Health Department
Riviera Beach, Florida, 33404
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Kansas City Free Health Clinic
Kansas City, Missouri, 64111
United States
Northstar Med Clinic
Chicago, Illinois, 60657
United States
Harbor - UCLA Med Ctr
Torrance, California, 90502
United States
Phoenix Body Positive
Phoenix, Arizona, 85006
United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 212870003
United States
North Shore Univ Hosp
Manhasset, New York, 11030
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
CRI New England
Brookline, Massachusetts, 02445
United States
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030
United States
Univ of Florida HSC
Jacksonville, Florida, 322096561
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ Hospital
Oklahoma City, Oklahoma, 73104
United States
Hosp Regional de Ponce
Ponce, , 00731
Puerto Rico
Infectious Disease Research Inst
Tampa, Florida, 33614
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Chandler Med Ctr
Lexington, Kentucky, 405360084
United States
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405
United States
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
United States
Southwest Infectious Diseases Associates
Dallas, Texas, 75246
United States
North Broward Hosp
Ft. Lauderdale, Florida, 33311
United States
Additional Information:
Study ID Numbers: 283E; GS-99-903
Study Start Date: March 2000
Record last reviewed: December 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005573
Other Hiv Infections Studies:
1. Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs
2. Escalating Multiple-Dose Safety and Tolerance of WR 6026 Hydrochloride in HIV-Infected Subjects
3. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease
4. Evaluation of the Therapeutic Benefit of r-metHuIFN- gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
5. A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Charlotte Clinical Trials
A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs
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