CLINICAL TRIAL ASSESSING ONCE DAILY RALTEGRAVIR ADMINISTRATION (800 mg QD) IN HIV-1-INFECTED PATIENTS RECEIVING UNBOOSTED ATAZANAVIR (400 mg QD)-BASED ANTIRETROVIRAL THERAPY (ENSAYO CLÍNICO PARA EVALUAR LA ADMINISTRACIÓN DE RALTEGRAVIR UNA VEZ AL DÍA (800 mg QD) EN PACIENTES INFECTADOS POR EL VIH-1 QUE RECIBEN TERAPIA ANTIRETROVIRAL BASADA EN ATAZANAVIR NO POTENCIADO (400 mg QD))

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002695-94-ES

Enrollment

Registered

2008-05-21

Start date

2008-07-21

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Infección por VIH-1 (HIV-1 infection) MedDRA version: 9.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection

Interventions

Trade Name: Isentress Pharmaceutical Form: Film-coated tablet INN or Proposed INN: raltegravir CAS Number: MK-0518 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 65 years old with documented HIV-1 infection. 2. Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks. 3. Complete virological suppression (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. AIDS defining condition within 4 weeks prior to the initiation of the study. 2. Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit. 3. Concomitant therapy with tenofovir. 4. History or suspected poor adherence to HAART. 5. History of drug allergy to raltegravir

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate raltegravir AUC24h and Cmin in HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir.;Secondary Objective: • To evaluate the proportion of patients with raltegravir Cmin lower than 33 nM (IC95 in the presence of 50% human serum). • To compare raltegravir AUC24h and Cmin between HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir and historical controls taking raltegravir 400 mg BID without atazanavir. • To evaluate safety of raltegravir 800 mg QD co-administered with atazanavir 400 mg QD in HIV-infected patients. ;Primary end point(s): To evaluate raltegravir AUC24h and Cmin in HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir.	—

Measure

Time frame

Main Objective: To evaluate raltegravir AUC24h and Cmin in HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir.;Secondary Objective: • To evaluate the proportion of patients with raltegravir Cmin lower than 33 nM (IC95 in the presence of 50% human serum). • To compare raltegravir AUC24h and Cmin between HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir and historical controls taking raltegravir 400 mg BID without atazanavir. • To evaluate safety of raltegravir 800 mg QD co-administered with atazanavir 400 mg QD in HIV-infected patients. ;Primary end point(s): To evaluate raltegravir AUC24h and Cmin in HIV-infected patients receiving antiretroviral therapy including raltegravir and unboosted atazanavir.

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Countries

Spain

Outcome results

None listed

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