A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs - Full Text View

Sponsor:	Gilead Sciences
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00005573

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Tenofovir disoproxil fumarate Drug: Efavirenz Drug: Lamivudine Drug: Stavudine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment
Official Title:	A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-Naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz Versus Stavudine, Lamivudine, and Efavirenz

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Lamivudine Tenofovir Efavirenz Tenofovir disoproxil Tenofovir Disoproxil Fumarate Stavudine

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	600
Study Start Date:	March 2000

Detailed Description:

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005573

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Locations

United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85006
United States, California
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Harbor - UCLA Med Ctr
Torrance, California, United States, 90502
Ocean View Internal Medicine
Long Beach, California, United States, 90803
Tower Infectious Disease Med Ctr
Los Angeles, California, United States, 90048
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
Univ of California, San Diego
San Diego, California, United States, 92103
Living Hope Clinical Trials
Long Beach, California, United States, 90813
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Univ of Florida HSC
Jacksonville, Florida, United States, 322096561
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 33136
Steinhart Medical Associates
Miami, Florida, United States, 33133
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
Hillsborough County Health Dept
Tampa, Florida, United States, 33602
South Shore Hosp
Miami, Florida, United States, 33139
Palm Beach County Health Department
Riviera Beach, Florida, United States, 33404
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Infectious Disease Research Inst
Tampa, Florida, United States, 33614
North Broward Hosp
Fort Lauderdale, Florida, United States, 33311
United States, Georgia
Mercer University School of Medicine
Macon, Georgia, United States, 31201
United States, Illinois
Chicago Ctr for Clinical Research
Chicago, Illinois, United States, 60610
Northstar Med Clinic
Chicago, Illinois, United States, 60657
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Kentucky
Chandler Med Ctr
Lexington, Kentucky, United States, 405360084
United States, Maryland
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, United States, 212870003
United States, Massachusetts
Boston Med Ctr
Boston, Massachusetts, United States, 02118
CRI New England
Brookline, Massachusetts, United States, 02445
CRI - Springfield
Springfield, Massachusetts, United States, 01107
Family Health Care Ctr at SSTAR
Fall River, Massachusetts, United States, 02720
United States, Missouri
Kansas City Free Health Clinic
Kansas City, Missouri, United States, 64111
United States, New York
St Vincents Hosp / Clinical Research Program
New York, New York, United States, 10011
Rockefeller Univ
New York, New York, United States, 10021
North Shore Univ Hosp
Manhasset, New York, United States, 11030
United States, North Carolina
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28203
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, United States, 275997030
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, United States, 27157
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, United States, 28207
Jemsek Clinic
Huntersville, North Carolina, United States, 28078
United States, Oklahoma
Univ Hospital
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
Miriam Hosp
Providence, Rhode Island, United States, 02906
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Coastal Carolina Research Ctr
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, United States, 75219
Univ of Texas Med Branch
Galveston, Texas, United States, 775550835
Southwest Infectious Diseases Associates
Dallas, Texas, United States, 75246
Gary Brewton
Houston, Texas, United States, 77098
Univ of Texas / Thomas Street Clinic
Houston, Texas, United States, 77030
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Virginia Commonwealth Univ
Richmond, Virginia, United States, 23298
United States, Washington
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, United States, 98405
Dominican Republic
Inst Dom De Estudios Virologicos
Santa Domingo, Dominican Republic
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 009091711
Hosp Regional de Ponce
Ponce, Puerto Rico, 00731
San Juan AIDS Program
Santurce, Puerto Rico, 00908

Sponsors and Collaborators

Gilead Sciences

More Information

Publications:

McGowan I, Cheng A, Coleman S, Johnson A, Genant H. Assessment of bone mineral density (BMD) in HIV-infected antiretroviral-therapy-naive patients. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 628)

Study ID Numbers:	283E, GS-99-903
Study First Received:	April 28, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005573 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
Stavudine
Lamivudine
RNA, Viral

Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
efavirenz

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Stavudine
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

Tenofovir disoproxil
Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009