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

Switching At Low HIV-1 RNA Into Fixed Dose Combinations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201210000439384

Enrollment

426

Registered

2012-10-19

Start date

2013-04-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

EFV-FDC

RPV-FDC

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Number of pt with plasma HIV-1 less then 400 copies per mL	—

Secondary

Measure	Time frame
Number 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	—

Measure

Time frame

Number 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

—

Countries

Uganda

Contacts

Public ContactS. Armstrong

Managing Director

sherry@crafrica.com+254 (0)702 707 764

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026