A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra® (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects - Phase IIb Dose Selection study for CCR5
- Conditions
- Treatment of HIV-1 infection
- Registration Number
- EUCTR2004-003865-33-ES
- Lead Sponsor
- GlaxoSmithKline S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1.HIV-1 infected subjects aged 13 years or older (or = 18 where required by local regulatory agencies). Females must fall into one of the following categories:
• Non-childbearing potential defined as women who are surgically sterile or post- menopausal, the latter indicated by history of no menses for a minimum of one year from the date of the screening visit.
•Childbearing potential: has a negative pregnancy test within 28 days prior to administration of investigational product
2.Screening plasma HIV-1 RNA = 50,000 copies/mL.
3.CD4 cell count >100 cells/mm3 at screening visit.
4.R5-tropic or R5/X4-tropic virus based on viral tropism assessment at screening visit. Not more than 20 subjects harboring R5/X4-tropic virus will be randomized.
5. ART-naïve, defined as = 2 weeks of treatment with either a PI or an NRTI/NtRTI, or = 7 days of therapy with an NNRTI.
6. Ability to understand and comply with protocol requirements
7. Signed and dated written informed consent .
Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range
1.Detection of plasma X4-tropic virus only at screening.
2.Subjects with active Class C AIDS-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition. Subjects with an historic or current CD4+ cell count nadir <200 cells/mm3 will not be excluded on that criterion. Subjects with a history of a CDC class C event will be permitted to enroll, providing they are not receiving any prohibited medications.
3.Any acute laboratory abnormality at screen
4.Significant blood loss (=500mL) within 56 days prior to the screening visit. 5.Pregnant women or women who are breastfeeding.
6.Any clinically significant finding on screening or baseline ECG.
7.History of clinically relevant pancreatitis or hepatitis within the previous 6 months [asymptomatic individuals with chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection will not be excluded.
8.Any condition which, in the opinion of the investigator, may interfere with the subject’s ability to comply with the dosing schedule and protocol evaluations
9.Any condition which, in the opinion of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug.
10.History of a drug or other allergy which, in the opinion of the investigator, contraindicates the subject’s participation in the study or known hypersensitivity to any study medication or excipients.
11.Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of investigational product administration or anticipated need for such treatment during the study.
12.Treatment with immunomodulating agents or any agent with known anti-HIV activity within 90 days of investigational product administration
13. Any immunization within 30 days prior to first dose of investigational product.
14. Previous participation in an experimental drug and/or vaccine trial(s) within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug – whichever is longer, prior to the screening visit of the study.
15. Use of prescription or OTC medications that are on the prohibited medication list.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method