Influence of Atorvastatin on Viral Replication During Antiretroviral Treatment Interruption

• Status: Terminated
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the influence of atorvastatin on plasma viral replication when the latter is given before and during highly active anti-retroviral therapy (HAART) in patients with HIV infection and viral suppression.

• Phase: Phase 4
• 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: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

1. Age >= 18 years.

2. Patients with chronic infection by HIV-1 in stable highly active antiretroviral treatment (>= 6 months).

3. Undetectable plasma viral load (<50 copies/mL) in the last 3 determinations over the last 6 months.

4. CD4 > 500 cells/mm>=3 in the last two determinations.

5. Documented prior viral load at some time of >15,000 copies/mL.

6. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.

7. Signature of the informed consent

Exclusion Criteria:

1. CD4 nadir <= 200 cells/mm3.

2. Background of infections or other AIDS-defining pathology.

3. Intercurrent infections in the last 6 months.

4. Creatine kinase (CK) >= 500 U/L.

5. AST or ALT >= 3 times higher than the upper limit of normality.

6. Treatment with others statins, fibrates, macrolides or fluconazole in the last 3 months.

7. Pregnancy or breastfeeding

8. Patients participating in another clinical trial