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A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
This study has suspended participant recruitment.
Sponsor:
Triangle Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002362
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 2000
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Purpose
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 | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Abacavir sulfate Drug: Efavirenz Drug: Emtricitabine Drug: Stavudine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| 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).
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: NCT00002362
Please refer to this study by its ClinicalTrials.gov identifier: 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
More Information
| ClinicalTrials.gov Identifier: | NCT00002362 History of Changes |
| Other Study ID Numbers: |
298B FTC-301 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Dideoxynucleosides Drug Therapy, Combination Stavudine |
Reverse Transcriptase Inhibitors abacavir efavirenz |
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 Efavirenz Emtricitabine Abacavir Dideoxynucleosides Stavudine Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective 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 Anti-HIV Agents Antimetabolites |
ClinicalTrials.gov processed this record on July 21, 2017