Adult HIV-1 infected patients Infections and Infestations HIV
Conditions
Interventions
Patients will be randomised to Continue Therapy (CT) or to Therapy Interruption (TI)
those treated with a NNRTI will discontinue the drug seven days before the nucleoside backbone. Standard antiretroviral drug doses will be used throughout the study period.
CT arm:
Clinical monito
Sponsors
Spanish AIDS Research Network (Red de Investigacion en SIDA [RIS]) (Spain)
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical (progression to AIDS, or any of the following HIV-associated clinical infections: oral candidiasis, multimetameric herpes zoster, leishmaniasis), virological (confirmed greater than 1000 copies/mL in CT arm and detectable viral load after six-month reintroduction of HAART in TI arm) or immunologic (confirmed CD4 < 200 cells/uL) failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to failure (assessed by log-rank test) 2. Switch due to toxicity (clinical and laboratory evaluation in every visit) 3. Lipid (total cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides measured in every visit) and body fat changes (by patient and physician clinical observation and anthropometric measures, at baseline and at one, two and three years) 4. Quality of life (assessed by Medical Outcomes Study HIV Health Survey [MOS-HIV] questionnaire at baseline and at one, two and three years) | — |
Countries
Spain
Outcome results
None listed