A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate Drug: Saquinavir |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
Official Title: | An Open-Label, Phase II Trial to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of 1592U89 in Combination With Selected HIV-1 Protease Inhibitors in Antiretroviral-Naive, HIV-1-Infected Patients. |
![](https://webarchive.library.unt.edu/web/20130317081948im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Local treatment for Kaposi's sarcoma.
- GM-CSF, G-CSF or erythropoietin.
Patients must have:
- HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture.
- CD4+ cell count >= 100 cells/mm3 within 14 days of study drug administration.
- HIV-1 RNA >= 5,000 copies/ml within 14 days of study drug administration.
- No active or ongoing AIDS-defining opportunistic infection or disease.
- Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
Prior Medication:
Allowed:
Local treatment for Kaposi's sarcoma.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication.
- Life-threatening infection or other serious medical condition that may compromise a patient's safety.
Concurrent Medication:
Excluded:
- Other investigational agents. NOTE:
- Those available through Treatment IND or expanded access programs are evaluated individually.
- Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma).
- Agents with documented anti-HIV activity in vitro.
- Foscarnet.
- Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons.
- Antioxidants.
Concurrent Treatment:
Excluded:
Radiation therapy within the first 24 weeks of study.
Patients with the following prior conditions are excluded:
- History of clinically relevant pancreatitis or hepatitis within the last 6 months.
- Participation in an investigational HIV-1 vaccine trial.
Prior Medication:
Excluded:
- Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy.
- Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
- HIV-1 vaccine dose within the 3 months prior to study drug administration.
- Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration.
Prior Treatment:
Excluded:
Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.
![](https://webarchive.library.unt.edu/web/20130317081948im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, California | |
UCSD Treatment Ctr | |
San Diego, California, United States, 921036329 | |
United States, Connecticut | |
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit | |
New Haven, Connecticut, United States, 065102483 | |
United States, Missouri | |
Kansas City AIDS Research Consortium | |
Kansas City, Missouri, United States, 64111 | |
United States, New York | |
NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Carolinas Med Ctr | |
Charlotte, North Carolina, United States, 28232 | |
United States, Ohio | |
Case Western Reserve Univ / AIDS Clinical Trials Unit | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Univ of Pittsburgh Med Ctr | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Vanderbilt Univ Med Ctr | |
Nashville, Tennessee, United States, 372321302 |
![](https://webarchive.library.unt.edu/web/20130317081948im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00002440 History of Changes |
Other Study ID Numbers: | 238J, CNAA2004 |
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:
HIV-1 Drug Therapy, Combination HIV Protease Inhibitors Mutation HIV-1 Reverse Transcriptase |
HIV Protease Reverse Transcriptase Inhibitors 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 Protease Inhibitors Indinavir Saquinavir Ritonavir |
Nelfinavir Amprenavir HIV Protease Inhibitors Anti-HIV Agents Abacavir Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors Antibiotics, Antitubercular |
ClinicalTrials.gov processed this record on March 14, 2013