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
2 other identifiers
interventional
30
1 country
2
Brief Summary
The purpose of this study is to see if it is safe to give a combination of four anti-HIV drugs to patients recently infected with HIV who have never received anti-HIV treatment. The effects of this combination of drugs on the immune system and the level of HIV in the body are studied also. The four-drug combination includes lamivudine, abacavir, amprenavir, and indinavir.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (2)
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021, United States
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-06