- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002233
A Study of a Combination of Four Drugs in Patients With Recent HIV Infection
A Phase II, 48-Week, Uncontrolled, Open-Label Study Designed to Evaluate the Safety and Efficacy of Quadruple Antiretroviral Therapy (EPIVIR, Abacavir, Amprenavir, and Indinavir) in Subjects Acutely Infected With HIV-1
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
New York
-
New York, New York, United States, 10021
- Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
-
-
Rhode Island
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Providence, Rhode Island, United States, 02906
- Miriam Hosp / Family Healthcare Ctr at SSTAR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed with caution and/or careful monitoring:
- Drugs which may interact at CYP3A4 (e.g., alprazolam, carbamazepine, codeine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, simvastatin, and warfarin).
- Drugs that inhibit cytosolic alcohol dehydrogenase (e.g., ethanol, disulfiram, chlorzoxazone, chlorpromazine, isoniazid, and chloral hydrate).
- Drugs known to affect renal tubular secretion (e.g., probenecid or cimetidine), cause liver toxicity, or induce myelosuppression.
Patients must have:
- Documented and confirmed acute HIV-1 infection.
- No prior exposure to antiretroviral treatment.
- Ability to comply with the investigational nature of the study for a minimum of 48 weeks.
- Consent of parent or guardian if under the age of 18.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- A clinical diagnosis of AIDS, excluding CD4+ cell counts less than 200/mm3.
- A serious medical condition such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that, in the opinion of the investigator, compromises the safety of the patient.
- Institutionalized or mentally disabled.
- Inability to comply with the dosing schedule and protocol evaluations for reasons other than those specified.
Concurrent Medication:
Excluded:
- Concurrent therapy with rifampin, rifabutin, terfenadine, astemizole, ketoconazole, itraconazole, cisapride, triazolam, midazolam, quinidine, amiodarone, and/or ergotamine/dihydroergotamine-containing regimens.
- Foscarnet or therapy with other agents with documented in vitro or in vivo activity against HIV-1.
- Medications known to induce or inhibit hepatic cytochrome P450 enzyme systems.
- Vitamin E supplements.
Concurrent Treatment:
Excluded:
- Dependence on blood transfusions.
- Other investigational treatments.
Patients with the following prior conditions are excluded:
- A history of clinically relevant pancreatitis or hepatitis within 6 months of study entry.
- A history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction that might interfere with drug absorption or render the patient unable to take oral medication.
- An unexplained fever above 38.5 Celsius for more than 14 days within 30 days of study entry.
- A history of coagulopathy.
Prior Medication:
Excluded:
- Prior exposure to antiretroviral therapy.
- Therapy with immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons, cytotoxic chemotherapeutic agents, or anti-oxidants within 30 days of study entry.
Prior Treatment:
Excluded:
- Radiation therapy within 30 days of study entry.
Risk Behavior:
Excluded:
Alcohol or illicit drug use which, in the opinion of the investigator, may interfere with ability to comply with the dosing schedule and protocol evaluations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Anti-Bacterial Agents
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitubercular Agents
- Antibiotics, Antitubercular
- Lamivudine
- Indinavir
- Abacavir
- Amprenavir
Other Study ID Numbers
- 264K
- COLA 2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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