A randomized, double-blind, placebo-controlled, phase II, dose finding, multicenter study to explore the safety, tolerability, efficacy, and pharmacokinetics of fosalvudine tidoxil capsules in antiretroviral naïve patients infected with HIV-1
- Conditions
- HIV-1 infected, clinically stable with not AIDS defining events
- Registration Number
- EUCTR2006-001107-10-DE
- Lead Sponsor
- Heidelberg Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
- HIV-1 infection documented by licensed HIV antibody ELISA and confirmed either by Western blot, positive HIV blood culture, positive HIV serum p24 antigen or plasma HIV-1 viremia
- No evidence of resistance to antiretroviral agents in a genotypic resistance test
- Plasma HIV-1 RNA load between 5.000 c/mL and 250.000 c/mL
- CD4+ T-cell count > 200 cells/mm3
- No prior AIDS-defining diagnosis (category C of the CDC classification)
- Antiretroviral treatment naïve, defined as less than 6 weeks of prior treatment with antiretroviral agents more than 3 months ago
- Males or non-lactating non-pregnant females
- Females of childbearing potential must have a negative urine pregnancy test at screening and prior to initial dosing on Day 1
- subjects of 18 years of age or older
- Able and willing to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Evidence of HIV-2 infection
- Evidence for chronic HBV and/or HCV infection
- Patients with acute HIV-1 infection
- Patients with the following laboratory parameters within 30 days prior to first dose of study drug: hemoglobin <7.0 mmol/L, neutrophil count <1000/mm3, platelet count <75,000/mm3, AST or ALT >2.5 times the upper limit of normal, amylase > 1.5 times the upper limit of normal, estimated creatinine clearance of <50 mL/min (using the Cockcroft formula)
- Patients with malabsorption syndromes affecting drug absorption (e.g., Crohn's disease, chronic pancreatitis)
- Patients enrolled in other investigational protocols or studies within the last 3 months
- Patients who have taken any prescribed medications within three weeks before the first dose of study drug, except for oral contraceptives by women and incidental use of analgesics
- History of alcohol or drug abuse within 6 months of the study
- Current or relevant previous history of serious, severe, or unstable (acute, or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures
- Patients who are, in the opinion of the investigator, unable to comply with the dosing schedule and protocol evaluations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate and compare for each dose group of 5mg, 10mg, 20mg and 40mg of HDP 99.0003:<br><br>- The safety and tolerability of 14 days dosing<br><br>- The antiretroviral efficacy of 14 days dosing;Secondary Objective: - To assess pharmacokinetics at each dose group<br><br>- To define the dose with the best benefit risk ratio for further clinical development;Primary end point(s): - Recording adverse events at the different doses of HDP 99.0003<br><br>- Change in plasma HIV-1 RNA levels from baseline to day 14.
- Secondary Outcome Measures
Name Time Method