A Study of Amprenavir in HIV-Infected Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002405|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
|First Submitted Date ICMJE||November 2, 1999|
|First Posted Date ICMJE||August 31, 2001|
|Last Update Posted Date||June 24, 2005|
|Study Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Study of Amprenavir in HIV-Infected Patients|
|Official Title ICMJE||Amprenavir (141W94) Open Label Protocol for Subjects With HIV-1 Infection Who Have Experienced Treatment Failure or Are Intolerant to Previous Protease Inhibitor Therapy|
The purpose of this study is to see if it is safe to give amprenavir (APV) to HIV-infected patients. This study also examines the effect APV has on the level of HIV in the blood.
Earlier studies have shown that APV is effective in slowing the growth of HIV in the body. Patients who have failed previous anti-HIV treatment or who are unable to take other protease inhibitors (PIs) may benefit from the availability of a new PI such as APV.
Earlier Phase II/III clinical trials indicate APV is effective in retarding HIV progression in the body. Despite these data, however, the drug has yet to receive regulatory approval. At the same time, there is an urgent need to grant pre-approval access to specific groups of patients eager to benefit from the anti-HIV potential inherent in APV. This study examines the relative effects APV has in patients with prior treatment failure or intolerance to previous protease inhibitor therapy.
Patients are seen in the clinic at pre-entry, baseline (Day 1), and every 4 weeks thereafter. Data on current antiretroviral treatment, HIV-1 associated conditions and adverse events are collected at every scheduled visit. Laboratory values (i.e., hematology, serum chemistry, plasma HIV-1 viral load and CD4+ cell count) are collected and assessed at pre-entry and Weeks 12, 24, 36, and 48. Optimal therapeutic effectiveness dictates the combined use of 2 or more antiretroviral agents in patients failing current antiretroviral therapy. APV, therefore, must be initiated as a component of a treatment regimen that also includes at least one other antiretroviral drug that the patient has not previously received.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Drug: Amprenavir|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
History of clinically relevant pancreatitis or hepatitis within the last 6 months.
Patients with current alcohol or illicit drug use which, in the investigator's opinion, may interfere with the patient's ability to comply with the requirements of the study.
Currently taking at least one nucleoside analogue or protease inhibitor, in addition to amprenavir.
|Ages||4 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00002405|
|Other Study ID Numbers ICMJE||264G|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Glaxo Wellcome|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||NIH AIDS Clinical Trials Information Service|
|Verification Date||April 1999|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP