A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment
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| ClinicalTrials.gov Identifier: NCT00002216 |
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Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate | Not Applicable |
In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens:
Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.
| Study Type : | Interventional (Clinical Trial) |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients. |
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- CD4 count > 50.
- HIV RNA > 5,000.
- No active AIDS (excluding CD4 count < 200).
- Ability to comply with dosing schedule and protocol evaluations.
Prior Medication:
Allowed:
- 3TC or any protease inhibitor, if < 1 week of therapy.
- Other nucleoside analogs, if < 4 weeks of therapy.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
- Active AIDS (not including CD4 count < 200).
- Malabsorption syndrome affecting drug absorption.
Concurrent Medication:
Excluded:
Enrollment in any other investigational drug protocol.
Prior Medication:
Excluded:
Non-nucleoside reverse transcriptase inhibitors.
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): NCT00002216
| United States, Pennsylvania | |
| Anderson Clinical Research | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| ClinicalTrials.gov Identifier: | NCT00002216 History of Changes |
| Other Study ID Numbers: |
280C UNAP 11 NZTA 4002 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | May 1999 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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Drug Therapy, Combination HIV Protease Inhibitors VX 478 |
Reverse Transcriptase Inhibitors Anti-HIV Agents abacavir |
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 Zidovudine Abacavir Lamivudine, zidovudine drug combination Nelfinavir Amprenavir |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites HIV Protease Inhibitors Protease Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents |