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 |
| Secondary identifying numbers | TTstudy-04 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Daniel Podzamczer
Scientific
Scientific
Infectious Disease Service
Hospital de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet
Barcelona
08907
Spain
| dpodzamczer@csub.scs.es |
Study information
| Study design | Prospective, multi-center, one-arm pilot trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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. |
| Secondary outcome measures | 1. CD4 changes, measured at baseline, week 12 and every 12 weeks thereafter up to the end of the study period. 2. Adverse effects. Clinical signs related to adverse effects are evaluated every 3 months 3. Resistance mutations if virologic failure 4. Clinical progression, evaluated every 3 months 5. Adherence to therapy, evaluated every 3 months |
| Overall study start date | 13/12/2004 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Infectious Disease Service
Barcelona
08907
Spain
08907
Spain
Sponsor information
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Research organisation
Research organisation
c/o Dr Asuncion Benito
Gran Via s/n Km 2,7 L'Hospitalet
Barcelona
08907
Spain
| abenito@idibell.org | |
| Website | http://www.idibell.es |
"ROR" |
https://ror.org/0008xqs48 |
Funders
Funder type
Research organisation
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
