Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination - Full Text View

Purpose

The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.

Condition	Intervention	Phase
HIV Infections	Drug: Emtricitabine Drug: Lamivudine	Phase 3


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label Equivalence Study of FTC Versus Lamivudine in Patients on a Stable Triple Antiretroviral Therapy Regimen Containing Lamivudine, Stavudine or Zidovudine, and a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Stavudine Zidovudine Lamivudine Emtricitabine

U.S. FDA Resources

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


Estimated Enrollment:	390

Detailed Description:

Patients are randomized to one of two arms in a 2:1 ratio (weighted to Arm 1). Arm 1: Replace lamivudine with FTC while continuing on current background regimen. Arm 2: Continue on current lamivudine-containing regimen. Patients are further stratified based upon screening plasma HIV-1 RNA and background therapy. Stratum 1: Less than 50 copies/ml; PI (protease inhibitor) in treatment regimen. Stratum 2: Less than 50 copies/ml; NNRTI (nonnucleoside reverse transcriptase inhibitor) in treatment regimen. Stratum 3: 50-400 copies/ml; PI in treatment regimen. Stratum 4: 50-400 copies/ml; NNRTI in treatment regimen. Clinic visits occur at regular intervals throughout the 48-week study period to determine viral load.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

You may be eligible for this study if you:

Are at least 18 years old.
Are HIV-positive.
Have a viral load below 400 copies/ml.
Agree to use a barrier method of birth control (such as condoms) during the study.
Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.)

Exclusion Criteria

You will not be eligible for this study if you:

Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry.
Have had a serious medical event within 30 days prior to study entry.
Are taking hydroxyurea.
Have Grade 2 or higher peripheral neuropathy.
Abuse alcohol or drugs.
Are pregnant or breast-feeding.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002416

Locations


United States, Florida
Dr Robert Wallace
St. Petersburg, Florida, United States, 33713
United States, New York
North Shore Univ Hosp
Great Neck, New York, United States, 11021

Sponsors and Collaborators

Triangle Pharmaceuticals

Investigators


Study Chair:	Charles van der Horst

More Information


ClinicalTrials.gov Identifier:	NCT00002416 History of Changes
Other Study ID Numbers:	298A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:


HIV-1 Zalcitabine Zidovudine Stavudine HIV Protease Inhibitors	Lamivudine RNA, Viral Reverse Transcriptase Inhibitors Anti-HIV Agents

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Zidovudine Emtricitabine	Stavudine Reverse Transcriptase Inhibitors Protease Inhibitors HIV Protease Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites

ClinicalTrials.gov processed this record on September 27, 2016