Status:
COMPLETED
A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination
Lead Sponsor:
Duke University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the antiretroviral efficacy, safety, and tolerability of fos-amprenavir boosted with either of two doses of ritonavir (RTV) when administered in combination wi...
Detailed Description
The optimal long-term management of HIV-1 infection necessitates the chronic use of highly effective, well-tolerated antiretroviral (ARV) combination therapy, which ideally can preserve future treatme...
Eligibility Criteria
Inclusion
- HIV-1 infection
- Male or Female 18 years of age or older
- Has plasma HIV-1 RNA (viral load) 1,000 or more copies/mL at screening
- Subject is antiretroviral-naïve ( less than 7 days of prior therapy with any agent
- Competency
- Not pregnant and willing to use effective birth control if applicable.
Exclusion
- Inability to comply due to pre-existing mental, physical, or substance abuse disorder or other reason.
- Has active/acute CDC Clinical Category C event at screening.
- Has history of inflammatory bowel disease, gastrointestinal malignancy, intestinal ischemia, malabsorption or other gastrointestinal dysfunction.
- Females who are pregnant or breastfeeding.
- Has a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the subject.
- Has ongoing clinically relevant pancreatitis or clinically relevant hepatitis at screening.
- Requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study drug administration.
- Has an acute laboratory abnormality at screening that, in the opinion of the investigator, should preclude the subject's participation in the study. Any Grade 4 laboratory result would exclude a subject from study participation.
- Has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for such a treatment within the study period.
- Requires treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to screening or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening.
- Has a history of allergy to any of the study drugs or any excipients therein.
- Is enrolled or plans to enroll in one or more investigational drug protocols, which may impact HIV RNA suppression.
- Requiring treatment with pharmacological agents for diabetes, or elevated triglycerides/cholesterol.
- Has an AST or ALT \>5 times the upper limit of normal (ULN).
- Has an estimated creatinine clearance \<50 mL/min via the Cockcroft-Gault method
- Subject requires treatment with any of the following medications within 28 days prior to study drug administration, or the anticipated need during the study: amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, halofantrine, lidocaine, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, terfenadine, and triazolam, carbamazepine, dexamethasone, phenobarbital, phenytoin, primidone, rifampin, and St. John's Wort (hypericum perforatum)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00335270
Start Date
March 1 2006
End Date
December 1 2007
Last Update
May 14 2013
Active Locations (1)
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1
University of Miami School of Medicine
Miami, Florida, United States, 33136