A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination
Completed · Phase 4
Conditions studied: HIV
In brief
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 with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 96 weeks in ART-naïve, HIV-infected adults
Key facts
- Study ID
- NCT00335270
- Run by
- Duke University
- People needed
- 100
- Starts
- 2006-03-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2013-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- University of Miami School of Medicine — Miami, Florida, United States
Full record on ClinicalTrials.gov
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