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| Descriptive Information Fields | |
| Brief Title † | A Study of a Combination of Four Drugs in Patients With Recent HIV Infection |
| Official Title † | 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 |
| 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. |
| Detailed Description | Patients receive a four-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (3TC and abacavir) and two protease inhibitors (amprenavir and indinavir) for a minimum of 48 weeks. At specified time points, patients undergo physical assessments and efficacy evaluations which include plasma HIV-1 RNA measurements and CD4 cell counts. Depending on the immunologic and virologic status of the patient, further testing may be done to determine whether quadruple drug therapy can attain undetectable viral levels. |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Open Label, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Amprenavir Drug: Lamivudine |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 30 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Concurrent Medication: Allowed with caution and/or careful monitoring:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
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. |
| Gender | Both |
| Ages | 15 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002233 |
| Organization ID | 264K |
| Secondary IDs †† | COLA 2012 |
| Study Sponsor † | Glaxo Wellcome |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | June 1999 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |