A randomised open-label study comparing the safety and efficacy of three different combination antiretroviral regimens as initial therapy for HIV infection. - Altair

• Conditions: Chronic HIV infection; MedDRA version: 8.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2006-004476-12-DE
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Inclusion criteria,
1. HIV-1 positive by licensed diagnostic test with presumed duration of infection > 6 months from date of randomisation.
2. Aged > 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate).
3. Antiretroviral treatment naïve.
4. Qualifying plasma HIV RNA = 2,000 copies/mL and a CD4+ T cell count of = 50 cells/µL.
5. No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing).
6. Calculated creatinine clearance (CLCr) >= 70 mL/min (Cockcroft-Gault formula).
Male: (140 - age in years) x (wt in kg) = CLCr (mL/min)
72 x (serum creatinine in mg/dL)

Female:(140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min)
72 x (serum creatinine in mg/dL)
7. Able 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria,
1.The following laboratory variables,
a). absolute neutrophil count (ANC) < 750 cells/µL
b). haemoglobin < 8.0 g/dL
c). platelet count < 50,000 cells/µL
d). serum AST, ALT > 5 x upper limit of normal (ULN)

2. Evidence of HLA-B57 or HLA B*5701 positivity
3. Pregnant or nursing mothers.
4. Current use of human growth hormone, testosterone or other anabolic steroid.
5. Current use of any prohibited medications as described in product specific information.
6. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation.
7. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
8. Patients unlikely to be able to remain in follow-up for the protocol-defined period.
9. Patients with known renal insufficiency.
10. Patients with obstructive liver disease.
11. Patients with intractable diarrhoea (six loose stools/day for at least seven consecutive days).
12. History of acute or chronic pancreatitis.
13. Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease.
14. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified