ALTAIR - Alternative Antiretroviral Strategies: A Comparison of Three Initial Regimens

Phase 4

Active, not recruiting

• Conditions: Human Immunodeficiency Virus - HIV; HIV+ treatment-naive patients; Infection - Acquired immune deficiency syndrome (AIDS / HIV)

• Registration Number: ACTRN12610001098022
• Lead Sponsor: The National Centre in HIV Epidemiology and Clinical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. HIV-1 positive by licensed diagnostic test with presumed duration of infection > or equal to 6 months from date of randomisation.
2. Antiretroviral treatment naïve.
3. Qualifying plasma HIV RNA > or equal to 2,000 copies/mL and a CD4+ T cell count of at 50 cells/microlitre.
4. No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing).
5. Calculated creatinine clearance (CLCr) > or equal to 70 mL/min (Cockcroft-Gault formula).
6.Able to provide written informed consent.

Exclusion Criteria

1. The following laboratory variables,
a). absolute neutrophil count (ANC) < or equal to 750 cells/Microlitre
b). haemoglobin < or equal to 8.0 g/dL
c). platelet count < or equal to 50,000 cells/microlitre
d). serum AST, ALT > or equal to 5 x upper limit of normal (ULN)
e). serum bilirubin > or equal to 1.5 x ULN
2. Pregnant or nursing mothers.
3. Current use of human growth hormone, testosterone or other anabolic steroid.
4. Current use of any prohibited medications as described in product specific information.
5. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation.
6. 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.
7. Patients unlikely to be able to remain in follow-up for the protocol-defined period.
8. Patients with known renal insufficiency.
9. Patients with obstructive liver disease.
10. Patients with intractable diarrhoea (six loose stools/day for at least seven consecutive days).
11. History of acute or chronic pancreatitis.
12. Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease.
13. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated).

Study & Design

• Study Type: Interventional
• Study Design: Not specified