Genotypic Tropism Testing In Proviral Dna To Guide CCR5 Antagonist Treatment In Subjects With Undetectable HIV-1 Viremia

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

CCR5 antagonists might be an adequate alternative for HIV-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity. The assessment of HIV-1 tropism in proviral DNA could be helpful to inform in which of these subjects CCR5 antagonists could be efficacious.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 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: Integrase Inhibitors; Maraviroc

Criteria

Inclusion Criteria:

1. HIV-1 infected patients.

2. Age 18 or more.

3. Antiretroviral treatment containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) plus 1 Non-nucleoside reverse-transcriptase inhibitor (NNRTI) or 1 protease inhibitor (PI) or 1 integrase inhibitor (ININ)

4. Patients receiving stable antiretroviral treatment for at least 6 months.

5. Viral load under 50 copies/mL in the last 6 months

6. Patients with CCR5 tropism based in V3 genotyping in proviral DNA using the G2P with a false positive rate of 10% interpretation method.

7. A change of treatment is needed due to toxicity / tolerability problems with the 3rd drug (PI, NNRTI or ININ), according to investigator criteria.

8. An antiretroviral regimen containing a CCR5-antagonist is suitable for the patient (physician criteria).

9. Voluntary written informed consent.

Exclusion Criteria:

1. Pregnancy or breast-feeding.

2. Patient previously treated with maraviroc.

3. Patients with documented resistance to maraviroc or any other drug considered for the new ARV regimen.

4. Viral failure in the moment of inclusion.

5. Bad adherence history or anticipated (investigator criteria).