Once-Daily Drug Regimen for HIV-Infected Patients
|ClinicalTrials.gov Identifier: NCT00001968|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
This study will examine the safety of giving antiviral therapy for HIV infection in a once-daily dosing schedule, and assess how well patients tolerate this regimen. A once a day dosing schedule may be easier for some people to follow than one that requires taking medicine 2 or 3 times a day. The ease of treatment is important, because not following the prescribed dosing regimen may make therapy less effective or ineffective.
HIV-infected patients 18 years and older who have never been treated for their infection may be eligible for this study. Candidates will be screened with a history and physical examination, including blood tests. Participants will take the following medications once a day: 1200 mg of amprenavir (8 capsules); 300 mg of ritonavir (3 capsules); 600 mg of abacavir (2 pills); and 300 mg of lamivudine (2 pills). Patients will have routine blood tests and be seen by a nurse or doctor, or both, at follow-up visits at weeks 2, 4, 8, 12, and 16; then every 8 weeks until week 48; and then every 3 months for up to 3 years. At week 2, a special blood test will be done over the course of a day to measure blood drug levels. For this test, blood samples will be drawn 8 times over a 24-hour period. A heparin lock (a device that allows the needle to remain in the vein) will be used to avoid multiple needle sticks.
|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome HIV Infections||Drug: Amprenavir Drug: Ritonavir Drug: Abacavir Drug: Lamivudine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Official Title:||A Pilot Study of Once-Daily Therapy With Amprenavir, Ritonavir, Lamivudine and Abacavir in HIV-Infected, Antiretroviral-Naive Patients|
|Study Start Date :||January 2000|
|Study Completion Date :||November 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001968
|United States, Maryland|
|National Institute of Allergy and Infectious Diseases (NIAID)|
|Bethesda, Maryland, United States, 20892|