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Sponsored by: |
Glaxo Wellcome |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002405 |
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.
Condition | Intervention |
HIV Infections |
Drug: Amprenavir |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | VX 478 |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | Amprenavir (141W94) Open Label Protocol for Subjects With HIV-1 Infection Who Have Experienced Treatment Failure or Are Intolerant to Previous Protease Inhibitor Therapy |
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.
Ages Eligible for Study: | 4 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
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.
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
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.
Required:
Currently taking at least one nucleoside analogue or protease inhibitor, in addition to amprenavir.
Required:
Study ID Numbers: | 264G |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002405 |
Health Authority: | United States: Food and Drug Administration |
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