Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART regimen with persistent HIV-1 viral suppression could increase the slope of decay of the HIV-1 latent reservoir.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria:

1. HIV-1 infected adults (+18 years old).

2. Complete virological suppression (<50 copies/mL) for += 12 months, including at least 3 times during the last year.

3. Patients on HAART regimen including a PI or an NNRTI and at least two nucleotide inhibitors.

4. Voluntary written informed consent.

Exclusion Criteria:

1. Pregnancy, or fertile women willing to be pregnant.

2. Active substance abuse or major psychiatric disease.

3. Presence of drug-related mutations or any polymorphism or mutation associated to MK-0518 resistance prior to first HAART (only if genotype is available).