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.

Sponsored by: Gilead Sciences
Information provided by: AIDS Clinical Trials Information Service

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 Treatment or Intervention Phase
HIV Infections
 Drug: Tenofovir disoproxil fumarate
 Drug: Efavirenz
 Drug: Lamivudine
 Drug: Stavudine
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

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

Location Information


Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85006,  United States

California
      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

Florida
      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

Georgia
      Mercer University School of Medicine, Macon,  Georgia,  31201,  United States

Illinois
      Chicago Ctr for Clinical Research, Chicago,  Illinois,  60610,  United States

      Northstar Med Clinic, Chicago,  Illinois,  60657,  United States

Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States

Kentucky
      Chandler Med Ctr, Lexington,  Kentucky,  405360084,  United States

Maryland
      Johns Hopkins Univ School of Medicine, Baltimore,  Maryland,  212870003,  United States

Massachusetts
      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

Missouri
      Kansas City Free Health Clinic, Kansas City,  Missouri,  64111,  United States

New York
      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

North Carolina
      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

Oklahoma
      Univ Hospital, Oklahoma City,  Oklahoma,  73104,  United States

Rhode Island
      Miriam Hosp, Providence,  Rhode Island,  02906,  United States

South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States

      Coastal Carolina Research Ctr, Mount Pleasant,  South Carolina,  29464,  United States

Texas
      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

Virginia
      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  United States

      Virginia Commonwealth Univ, Richmond,  Virginia,  23298,  United States

Washington
      Infections Ltd / Physicians Med Ctr, Tacoma,  Washington,  98405,  United States

Dominican Republic
      Inst Dom De Estudios Virologicos, Santa Domingo,  Dominican Republic

Puerto Rico
      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

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
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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