Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC

• Register: ClinicalTrials.gov
• Last refreshed on: 30 March 2015
• Main ID: NCT00338390
• Date of registration: 15/06/2006
• Prospective Registration: No
• Primary sponsor: Hospital de Granollers
• Public title: Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC
• Scientific title: Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI + Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI + Tenofovir With Abacavir + Lamivudine in a Single Tablet
• Date of first enrolment: April 2005
• Target sample size: 75
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00338390
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Spain

Contacts

• Name: Enric Pedrol, MD, PhD
• Affiliation: Fundació Hospital de Granollers

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years.

- HIV-1 infected patients.

- Patients on triple HAART therapy including ddI + tenofovir plus a PI or NNRTI for at
least 3 months.

- Patients with an undetectable HIV-1 viral load (< 50 copies RNA / mL or < centre's
limit of detection) over the last 6 months.

- Not be on treatment with immunosuppressives, such as: hydroxyurea, interferon,
ribavirin or cytostatics.

- Not be on treatment with interleukin-2 or other immunomodulators.

- 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.

- Signature of the informed consent.

Exclusion Criteria:

- Incapacity to give informed consent.

- Bad adherence or treatment interruptions over the previous 6 months.

- Prior exposure to abacavir.

- HAART Therapy including ddI at a dose of 400mg + tenofovir if weight > 60 kg or ddI
250 mg + tenofovir if weight < 60 kg.

- Suspicion of cross resistances to abacavir and lamivudine.

- Hepatic or pancreatic analytical alterations 4 times above the limit of normality.

- Presence of opportunistic infections and/or recent tumours (< 6 months).

- Patients participating in another clinical trial.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Didanosine

Drug: Abacavir

Drug: Abacavir+Lamivudine

Primary Outcome(s)

Proportion of patients that increase their number of CD4 lymphocytes with regard to the baseline. [Time Frame: At 12, 24, 36 and 48 weeks]

Secondary Outcome(s)

Incidence of new laboratory alterations that appear during the follow-up period (change in renal parameters, changes in lactate levels, modification of pancreatic enzymes, changes in lipid parameters). [Time Frame: during the follow-up period]

Evolution of the laboratory alterations that were already present at the time they were included in the study. [Time Frame: during the 48 weeks of follow-up]

Evolution of the clinical adverse events that were already present at the time they were included in the study. [Time Frame: during the 48 weeks of follow-up]

Incidence of new clinical adverse events that appear . [Time Frame: during 48 weeks of follow-up]

Rate of treatment drop-outs due to the appearance of adverse events [Time Frame: during the 48 weeks of follow-up]

To evaluate the proportion of patients with viral load of HIV-1 <50 copies of the combinations studied during the follow-up period. [Time Frame: At 12, 24, 36 and 48 weeks.]

Secondary ID(s)

2004-003749-42

EUROPA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors