DINAMICA VIRAL DEL VIH-1 EN SUJETOS QUE INICIAN TERAPIA CON RALTEGRAVIR (HIV-1 VIRAL DYNAMICS IN SUBJECTS INITIATING RALTEGRAVIR THERAPY)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005951-40-ES

Enrollment

Registered

2008-01-29

Start date

2008-02-07

Completion date

Unknown

Last updated

2012-04-24

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

Conditions

Pacientes con infección VIH-1 (HIV-1 infection) MedDRA version: 9.1 Level: LLT Classification code 10000807 Term: Acute HIV infection

Interventions

Product Name: raltegravir Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance. - Subjects initiating raltegravir plus another fully active antiretroviral drug 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy, or fertile women willing to be pregnant. - Active substance abuse or major psychiatric disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine first- and second-phase decay rates of plasma HIV-1 RNA in subjects starting raltegravir therapy.;Secondary Objective: Quantify changes in the intracellular levels of HIV-1 proviral DNA and LTR circles during raltegravir therapy. ;Primary end point(s): Determine first- and second-phase decay rates of plasma HIV-1 RNA in subjects starting raltegravir therapy.	—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026