Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy

NCT00718536 | Completed Phase 4

• 1 other identifier: RALqd-ATV
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are recovered.

Conditions

HIV Infections

Keywords

Atazanavir; Raltegravir; once-daily; pharmacokinetics; HIV

Outcome Measures

Primary Outcomes (1)

• Raltegravir area under the curve (AUC) 24 hours and Cmin

  Day 10

Secondary Outcomes (2)

• Adverse events

  Baseline (BL), Day 10

• Adherence

  BL, Day 10

Study Arms (1)

1

EXPERIMENTAL

Addition of raltegravir 800 mg QD to HAART

Drug: Addition of raltegravir 800 mg QD to HAART

Interventions

Addition of raltegravir 800 mg QD to HAART DRUG

Addition of raltegravir 800 mg QD to HAART

Also known as: HAART+RAL

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 65 years old with documented HIV-1 infection.
• Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks.
• Complete virological suppression (\<50 copies/mL) for at least 12 months.
• Voluntary written informed consent.
• Ability of compliance with visit schedule.

You may not qualify if:

• AIDS defining condition within 4 weeks prior to the initiation of the study.
• 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.
• Concomitant therapy with tenofovir.
• History or suspected poor adherence to HAART.
• History of drug allergy to raltegravir

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Clotet Bonaventura, MD,PhD

  Lluita contra la Sida Foundation, HIV Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

ES (1)