A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00002362 |
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Recruitment Status
:
Suspended
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
- Study Details
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- No Results Posted
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Brief Summary:
This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Abacavir sulfate Drug: Efavirenz Drug: Emtricitabine Drug: Stavudine | Phase 3 |
Patients are randomized to receive open-label emtricitabine or ABC in combination with stavudine and efavirenz. Viral load and CD4+ cell counts are compared at Weeks 24 and 48. Patients are followed for 48 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients |
| Study Start Date : | August 1999 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
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 if you:
- Are HIV-positive and generally healthy.
- Have a viral load of 5,000 copies/ml or more.
- Have CD4 cell counts of 200 cells/mm3 or more.
- Are age 18 or older.
- Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms).
Exclusion Criteria
You will not be eligible if you:
- Have ever taken anti-HIV drugs for 3 days or more.
- Have had certain AIDS-related infections.
- Have had severe diarrhea within the past 30 days.
- Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain.
- Are being treated for active tuberculosis (TB).
- Are pregnant or breast-feeding.
- Use illegal drugs or alcohol that make it difficult for you to take study drugs or keep clinic appointments.
- Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail).
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): NCT00002362
Locations
| United States, California | |
| Ctr for AIDS Research / Education and Service (CARES) | |
| Sacramento, California, United States, 95814 | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| United States, Florida | |
| Gary Richmond MD | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Illinois | |
| Northstar Med Clinic | |
| Chicago, Illinois, United States, 60657 | |
| United States, New Jersey | |
| South Jersey Infectious Diseases Inc | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, New York | |
| North Shore Univ Hosp / Div of Infectious Diseases | |
| Manhasset, New York, United States, 11030 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77006 | |
| Univ of Texas / Med School at Houston | |
| Houston, Texas, United States, 77030 | |
| Univ of Texas Health Sciences Ctr | |
| San Antonio, Texas, United States, 78284 | |
Sponsors and Collaborators
Triangle Pharmaceuticals
| ClinicalTrials.gov Identifier: | NCT00002362 History of Changes |
| Other Study ID Numbers: |
298B FTC-301 |
| 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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Dideoxynucleosides Drug Therapy, Combination Stavudine |
Reverse Transcriptase Inhibitors abacavir efavirenz |
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 Emtricitabine Efavirenz Abacavir Dideoxynucleosides Stavudine Antiviral Agents |
Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites |