A phase IIb, 96 week, randomised, partially,double-blinded,multicentre,parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with COMBIVIR ( lamividine and Zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults
- Conditions
- Treatment of HIV-1 infections
- Registration Number
- EUCTR2004-003866-13-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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.
•Childbearing potential: has a negative pregnancy test within 28 days prior to administration of investigational products and agrees to use a proven double barrier method of contraception.
2.Screening plasma HIV-1 RNA = 10,000 copies/mL.
3.CD4 cell count > 100 cells/mm3 at screening.
4.R5-tropic virus at screening.
5.No drug resistance mutations in HIV-1 RT based on pol genotype determined at screening.
6.ART-naïve, defined as = 2 weeks of treatment with either a PI or an NRTI/NtRTI, or < 7 days of therapy with an NNRTI. Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) will not be permitted.
7.Ability to understand and comply with protocol requirements
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)
F.1.3.1 Number of subjects for this age range
1.Detection of any X4-tropic virus, at screening.
2.Detection of any resistance-conferring mutation in HIV-1 RT based on genotypic testing at screening.
3Subject 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
4.Any acute laboratory abnormality at screen
5.Significant blood loss within 56 days prior to screening.
6.Pregnant or lacatating women
7.Any clinically significant finding on screening or baseline ECG.
8.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
9.Any condition may interfere with subject’s ability to comply with the dosing schedule and protocol evaluations or compromise safety of subject.
10.Any condition which might interfere with ADME of drug
11.History of a drug or other allergy or known hypersensitivity to any study medication or excipients.
12.Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of administration.
13.Treatment with immunomodulating agents or any agent with known anti-HIV activity within 90 days of administration.
14.Any immunisation within 30 days prior to first dose.
15.Prior investigational drug and/or vaccine trial(s) within 30 days or 5 half-lives, or twice the duration of the biological effect(whichever is longer), prior screening.
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