A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs - Article Sustiva
Clinical Trial: A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs
This study has been completed.
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||Treatment or Intervention||Phase|
|HIV Infections || Drug: Tenofovir disoproxil fumarate |
|Phase III |
MedlinePlus related topics: AIDS
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
Expected Total Enrollment: 600
Study start: March 2000
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.
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
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.
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.
Phoenix Body Positive, Phoenix, Arizona, 85006, United States
San Francisco Veterans Administration Med Ctr, San Francisco, California, 94121, United States
Harbor - UCLA Med Ctr, Torrance, California, 90502, United States
Pacific Oaks Med Group, Beverly Hills, California, 90211, United States
Tower Infectious Disease Med Ctr, Los Angeles, California, 90048, United States
Ocean View Internal Medicine, Long Beach, California, 90803, United States
Univ of California, San Diego, San Diego, California, 92103, United States
Living Hope Clinical Trials, Long Beach, California, 90813, United States
District of Columbia
George Washington Univ Med Ctr, Washington, District of Columbia, 20037, United States
Georgetown Univ Med Ctr, Washington, District of Columbia, 20007, United States
Steinhart Medical Associates, Miami, Florida, 33133, United States
Univ of Miami / Jackson Memorial Hosp, Miami, Florida, 33136, United States
Univ of Florida HSC, Jacksonville, Florida, 322096561, United States
Treasure Coast Infectious Disease Consultants, Vero Beach, Florida, 32960, United States
Hillsborough County Health Dept, Tampa, Florida, 33602, United States
South Shore Hosp, Miami, Florida, 33139, United States
Palm Beach County Health Department, Riviera Beach, Florida, 33404, United States
North Broward Hosp, Fort Lauderdale, Florida, 33311, United States
Infectious Disease Research Inst, Tampa, Florida, 33614, United States
IDC Research Initiative, Altamonte Springs, Florida, 32701, United States
Mercer University School of Medicine, Macon, Georgia, 31201, United States
Chicago Ctr for Clinical Research, Chicago, Illinois, 60610, United States
Northstar Med Clinic, Chicago, Illinois, 60657, United States
Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States
Chandler Med Ctr, Lexington, Kentucky, 405360084, United States
Johns Hopkins Univ School of Medicine, Baltimore, Maryland, 212870003, United States
Boston Med Ctr, Boston, Massachusetts, 02118, United States
CRI New England, Brookline, Massachusetts, 02445, United States
CRI - Springfield, Springfield, Massachusetts, 01107, United States
Family Health Care Ctr at SSTAR, Fall River, Massachusetts, 02720, United States
Kansas City Free Health Clinic, Kansas City, Missouri, 64111, United States
North Shore Univ Hosp, Manhasset, New York, 11030, United States
Rockefeller Univ, New York, New York, 10021, United States
St Vincents Hosp / Clinical Research Program, New York, New York, 10011, United States
Carolinas Med Ctr, Charlotte, North Carolina, 28203, United States
Univ of North Carolina / SOCA, Chapel Hill, North Carolina, 275997030, United States
Wake Forest Univ School of Medicine, Winston Salem, North Carolina, 27157, United States
Nalle Clinic / Clinical Research Dept, Charlotte, North Carolina, 28207, United States
Jemsek Clinic, Huntersville, North Carolina, 28078, United States
Univ Hospital, Oklahoma City, Oklahoma, 73104, United States
Miriam Hosp, Providence, Rhode Island, 02906, United States
Julio Arroyo, West Columbia, South Carolina, 29169, United States
Coastal Carolina Research Ctr, Mount Pleasant, South Carolina, 29464, United States
N Texas Ctr for AIDS & Clin Rsch, Dallas, Texas, 75219, United States
Univ of Texas Med Branch, Galveston, Texas, 775550835, United States
Univ of Texas / Thomas Street Clinic, Houston, Texas, 77030, United States
Gary Brewton, Houston, Texas, 77098, United States
Southwest Infectious Diseases Associates, Dallas, Texas, 75246, United States
Hampton Roads Med Specialists, Hampton, Virginia, 23666, United States
Virginia Commonwealth Univ, Richmond, Virginia, 23298, United States
Infections Ltd / Physicians Med Ctr, Tacoma, Washington, 98405, United States
Inst Dom De Estudios Virologicos, Santa Domingo, Dominican Republic
San Juan AIDS Program, Santurce, 00908, Puerto Rico
Hosp Regional de Ponce, Ponce, 00731, Puerto Rico
Clinical Research Puerto Rico Inc, San Juan, 009091711, Puerto Rico
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)
Record last reviewed: December 2000
Last Updated: October 13, 2004
Record first received: April 28, 2000
ClinicalTrials.gov Identifier: NCT00005573
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005