Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: Abacavir (Drug); Amprenavir (Drug); Efavirenz (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
This study will continue to treat and collect safety and efficacy data on patients who
participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir,
amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of
Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects
with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a
Protease Inhibitor-Containing Regimen).
HIV-infected patients 18 years of age and older who participated in the above study at the
NIH site may be eligible for the current study. Participants will be followed every 3 months
with a general health evaluation and laboratory tests. This is a NIH study, and information
will not be provided to Glaxo Wellcome
Clinical Details
Official title: Continued Salvage Anti-Retroviral Therapy With Abacavir, Amprenavir, and Efavirenz
Study design: Treatment, Safety/Efficacy Study
Detailed description:
In this open-label, single-arm study, HIV-1 infected patients who had, at study entry, a
viral burden of at least 500 copies/mL despite 20 weeks of treatment with a protease
inhibitor receive combination therapy with three antiretroviral agents that were
investigational at the start of study but have since been approved: abacavir, amprenavir,
and efavirenz. At the end of 16 weeks, the addition of other antiretroviral agents to the
study regimen was permitted. This was originally a multi-center study, but it has been
closed at all other sites. It remains open at the NIH to continue to provide therapy to
subjects who have received benefit as determined by a decline in viral load from baseline.
Safety and viral load data continue to be collected.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
INCLUSION/EXCLUSION CRITERIA:
Subjects who were previously enrolled in this protocol when it was a multi-center study and
who signed the new informed consent were enrolled. There has been and will be no other new
enrollment. Thus, subjects who were not previously enrolled are excluded.
Subjects are adults infected with HIV-1 who had, prior to study enrollment, a plasma viral
load of at least 500 copies/mL despite at least 20 weeks of treatment with a protease
inhibitor and without change in protease inhibitor therapy in the 12 weeks prior to
enrollment.
Locations and Contacts
National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland 20892, United States
Additional Information
Related publications: Livington DJ, Pazhanisamy S, Porter DJ, Partaledis JA, Tung RD, Painter GR. Weak binding of VX-478 to human plasma proteins and implications for anti-human immunodeficiency virus therapy. J Infect Dis. 1995 Nov;172(5):1238-45. Partaledis JA, Yamaguchi K, Tisdale M, Blair EE, Falcione C, Maschera B, Myers RE, Pazhanisamy S, Futer O, Cullinan AB, et al. In vitro selection and characterization of human immunodeficiency virus type 1 (HIV-1) isolates with reduced sensitivity to hydroxyethylamino sulfonamide inhibitors of HIV-1 aspartyl protease. J Virol. 1995 Sep;69(9):5228-35. Tisdale M, Myers RE, Maschera B, Parry NR, Oliver NM, Blair ED. Cross-resistance analysis of human immunodeficiency virus type 1 variants individually selected for resistance to five different protease inhibitors. Antimicrob Agents Chemother. 1995 Aug;39(8):1704-10.
Starting date: November 1997
Ending date: August 2003
Last updated: March 3, 2008
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