Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination
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| ClinicalTrials.gov Identifier: NCT00002416 |
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Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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Sponsor:
Triangle Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Emtricitabine Drug: Lamivudine | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 390 participants |
| 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 the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Lamivudine
U.S. FDA Resources
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| ClinicalTrials.gov Identifier: | NCT00002416 History of Changes |
| Other Study ID Numbers: |
298A |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | March 2000 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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HIV-1 Zalcitabine Zidovudine Stavudine HIV Protease Inhibitors |
Lamivudine RNA, Viral Reverse Transcriptase Inhibitors Anti-HIV Agents |
Additional relevant MeSH terms:
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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 Emtricitabine Zidovudine |
Reverse Transcriptase Inhibitors Stavudine 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 |