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:	Intervention Model: Parallel Assignment Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/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

Show 55 Study Locations

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)

ClinicalTrials.gov Identifier:	NCT00005573 History of Changes
Other Study ID Numbers:	283E, GS-99-903
Study First Received:	April 28, 2000
Last Updated:	June 23, 2005
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Stavudine
Lamivudine
Reverse Transcriptase Inhibitors

Tenofovir disoproxil
Tenofovir
Efavirenz
Anti-HIV Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012