Evaluation of the benefit and the safety of a CD4-guided Highly Active Anti-Retroviral Therapy (HAART) interruption strategy in stable adult Human Immunodeficiency Virus (HIV)-infected patients

Completed

• Conditions: Adult HIV-1 infected patients; Infections and Infestations; HIV

• Registration Number: ISRCTN75856952
• Lead Sponsor: Spanish AIDS Research Network (Red de Investigacion en SIDA [RIS]) (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 170

Inclusion Criteria

1. Adult HIV-1 infected patients treated with HAART (two Nucleoside analogue Reverse Transcriptase Inhibitors [NRTIs] plus a Non-Nucleoside Reverse Transcriptase Inhibitor [NNRTI] or two NRTIs plus one or two Protease Inhibitors [PIs])
2. Stable clinical status without HAART changes in the last six months
3. Undetectable viral load (less than 50 copies/mL) in the last six months
4. CD4 greater than 500 cell/mm^3 in the last three months
5. No more than a previous virological failure leading to HAART modification
6. Written informed consent

Exclusion Criteria

1. Previous Acquired Immune Deficiency Syndrome (AIDS) (except oesophageal candidiasis, pulmonary tuberculosis, recurrent pneumonia and wasting syndrome)
2. CD4 nadir less than 100 cells/mm^3
3. Positive Hepatitis B surface Antigen (HBsAg) using tenofovir and/or lamivudine
4. Child C-cirrhosis
5. Current therapy with immunosuppressive or immunomodulator drugs (including interleukines and interpheron), corticosteroids or chemotherapy
6. Current and previous treatment with HIV-immunogen drugs
7. Pregnancy or breast feeding
8. Patients included in other clinical trials or experimental studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified