A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs
This study has been completed.
Sponsor:
Glaxo Wellcome
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002217
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1999
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Purpose
The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Amprenavir |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have:
- CD4 count greater than 50 cells/mm3.
- HIV RNA less than 50,000 copies/ml.
- No active AIDS (excluding CD4 count less than 200 cells/mm3).
- Ability to comply with dosing schedule and protocol evaluations.
Prior Medication:
Allowed:
AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
- Active AIDS (not excluding CD4 count less than 200).
- Malabsorption syndrome affecting drug absorption.
- Serious medical condition that would compromise safety of the patient.
Concurrent Medication:
Excluded:
- AZT or NNRTIs.
- More than 1 week treatment with any protease inhibitor.
- Enrollment in any other investigational drug protocol.
Patients with the following prior conditions are excluded:
History of clinically relevant pancreatitis or hepatitis within the past 6 months.
Required:
Antiretroviral therapy with either single or double reverse transcriptase inhibitors.
Contacts and Locations More Information
Publications:
Henry K, Shaeffer M, Ross L, Johnson M, Fisher R, Liao Q, Graham N. Response to Combivir and abacavir given bid to nucleoside experienced patients is not affected by the presence of the M184V mutation. 6th Conf Retro and Opportun Infect. 1999 Jan 31 - Feb 4 (abstract no 132)
| ClinicalTrials.gov Identifier: | NCT00002217 History of Changes |
| Other Study ID Numbers: | 280D, UNAP 12, NZTA 4005 |
| 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:
|
Drug Therapy, Combination Patient Compliance Anti-HIV Agents abacavir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine Abacavir Lamivudine, zidovudine drug combination |
Amprenavir Anti-HIV Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents |
ClinicalTrials.gov processed this record on May 21, 2013