A Study to Compare Efficacy in Terms of Plasma HIV-1 RNA Between 2 Fixed Dose Combinations After a Switch in Fully Suppressed Patients

Not Applicable

• Conditions: HIV/AIDS

• Registration Number: PACTR201210000439384
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-19
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

Documented human immunodeficiency virus-type 1 (HIV-1) infection
- Patients who have been receiving first line highly active antiretroviral therapy (HAART) for at least 1 year before the screening visit
- Patients who prefer to change the current HAART regimen for reasons of simplification and/or due to toxicity of nucleoside/nucleotide reverse transcriptase inhibitor (N[t]RTI)
- Antiretroviral (ARV) combination treatment for at least 8 weeks before the screening visit and expected to continue on the same regimen throughout the screening period
- Plasma HIV-1 RNA less than 50 copies per mL and cluster of differentiation 4 positive (CD4+) cell count more than 200 per cubic millimeter
- Agrees to protocol-defined use of effective contraception

Exclusion Criteria

- History of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than or equal to 400 copies per mL) and immunologic failure (2 consecutive CD4+ cell counts) while on previous or current ART
- History of any primary N[t]RTI or NNRTI mutations below the pre HAART level
- Significantly decreased hepatic function or hepatic insufficiency or diagnosed with acute clinical viral hepatitis
- Diagnosed with Mycobacterium tuberculosis infection
- Severe laboratory abnormalities
- Creatinine clearance less than 50 mL per minute
- Addicted to drug, including alcohol or recreational drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of pt with plasma HIV-1 less then 400 copies per m

Secondary Outcome Measures

Name	Time	Method
umber of patients with plasma HIV-1 RNA levels less than 50 copies per mL;Number of patients with plasma HIV-1 RNA levels more than or equal to 400 copies per mL;Number of patients with plasma HIV-1 RNA levels more than or equal to 50 copies per mL;Number of patients with treatment-emergent nucleoside reverse transcriptase inhibitor (N[t]RTI) or nucleoside/nucleotide reverse transcriptase inhibitor (NNRTI) mutations;Number of adherent patients based on tablet count;Number of patients with adverse events