Prospective, multi-center, one-arm pilot trial of Trizivir plus Tenofovir in adult HIV-infected antiretroviral-naive patients
| ISRCTN | ISRCTN19938041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19938041 |
| Protocol serial number | TTstudy-04 |
| Sponsor | Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain) |
| Funder | Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain) |
- Submission date
- 14/09/2007
- Registration date
- 25/09/2007
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Infectious Disease Service
Hospital de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet
Barcelona
08907
Spain
| dpodzamczer@csub.scs.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, multi-center, one-arm pilot trial. |
| Secondary study design | Non randomised controlled trial |
| Scientific title | Prospective, multi-center, one-arm pilot trial of Trizivir plus Tenofovir in adult HIV-infected antiretroviral-naive patients |
| Study acronym | TT |
| Study objectives | A combination of trizivir plus tenofovir will be associated with a good efficacy and tolerability in antiretroviral naive patients, even in those with high baseline viral loads and low CD4 counts. |
| Ethics approval(s) | 1. Local ethical committee, approved on November 10, 2004 2. National Health Authorities (Agencia Española del Medicamento), approved on November 18, 2004 |
| Health condition(s) or problem(s) studied | HIV infection |
| Intervention | All participants will initiate an antiretroviral regimen of Trizivir® (Active ingredients: zidovudine 300 mg + lamivudine 150 mg + abacavir 300 mg) 1 pill orally twice a day (bid) plus tenofovir 300 mg orally everyday (qd). The duration of the intervention is 2 years prolonged to a third if efficacy and tolerability are acceptable. |
| Intervention type | Other |
| Primary outcome measure(s) |
Viral load <50 copies/mL. Viral load is measured at baseline, week 2, 4, 12 and every 12 weeks thereafter up to the end of the study period. |
| Key secondary outcome measure(s) |
1. CD4 changes, measured at baseline, week 12 and every 12 weeks thereafter up to the end of the study period. |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 93 |
| Key inclusion criteria | 1. Confirmed HIV infection 2. Age >= 18 years 3. AntiRetroViral (ARV) naive 4. CD4 > 100 cells/uL 5. Written informed consent |
| Key exclusion criteria | 1. Alanine aminotransferase >5 Upper Limit of Normal (ULN) 2. Hepatic cirrhosis 3. Renal insufficiency with creatinine clearance <50 ml/min 4. Haemoglobin (Hb) <9 g/dL 5. Neutrophils <1,000/uL 6. Platelets <30,000/uL 7. Pregnancy 8. Acute infection in the last two weeks 9. Systemic treatment for neoplasms 10. Hepatitis C Virus+ (HCV+) in patients who require treatment with interferon/ribavirin |
| Date of first enrolment | 13/12/2004 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
08907
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2008 | 23/10/2020 | Yes | No |
Editorial Notes
23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
