A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 with ABC/3TC (abacavir/lamivudine, Epzicom®) FDC (fixed dose combination) in a once-daily regimen over 96 weeks in ART-naïve, HIV-infected adults

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: GlaxoSmithKline
• Treatments: Abacavir; Amprenavir; Calcium; Fosamprenavir; Lamivudine; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)