Evaluation of two Trizivir-based strategies of induction-maintenance in antiretroviral-naive HIV-infected patients
| ISRCTN | ISRCTN41611080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41611080 |
| Secondary identifying numbers | TRIZEFAL |
- Submission date
- 12/09/2005
- Registration date
- 19/01/2006
- Last edited
- 24/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Gatell
Scientific
Scientific
Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain
| Phone | +34 (0)932275430 |
|---|---|
| gatell@medicina.ub.es |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To assess the virological and immunological response in naive patients undergoing induction (24 weeks of intensive therapy with three nucleoside reverse transcriptase inhibitors [NRTIs] plus either a protease inhibitor or a non-nucleoside) followed by 48 weeks of maintenance therapy with three NRTIs. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Human immunodeficiency virus (HIV) infection |
| Intervention | Patients are randomly assigned to receive either: 1. Retrovir (AZT) + Lamivudine (3TC) + Trizivir (ABC) + Efavirenz (Sustiva), or 2. AZT + 3TC + ABC + Lopinavir/Ritonavir (Kaletra) After 24 weeks, patients in both arms showing undetectable viral load will receive Trizivir for 48 more weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Trizivir (ABC), Lamivudine (3TC), Retrovir (AZT), Efavirenz (Sustiva), Lopinavir/ritonavir (Kaletra) |
| Primary outcome measure | Proportion of patients with viral load below 20 copies/ml (polymerase chain reaction [PCR] estandar, Amplicor Monitor Roche Ultrasensible) at 72 weeks. |
| Secondary outcome measures | 1. Proportion of patients with CD4+ cell count above 200 c/ml at 72 weeks 2. Proportion of patients with viral load <20 copies/ml at 24 weeks 3. Time to treatment failure 4. Duration of response 5. Incidence of adverse events (clinical and laboratory) leading to discontinuation of the study drugs 6. Incidence of C events (CDC 1993) 7. Death for any cause |
| Overall study start date | 15/04/2003 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Key inclusion criteria | 1. Male and female 2. HIV-1 infection 3. Age 18 or above 4. Antiretroviral-naive 5. Plasma viral load above 10,000 copies/ml 6. Life expectancy >72 weeks 7. Written informed consent |
| Key exclusion criteria | 1. Pregnancy, breastfeeding or intention to become pregnant during the study planned duration 2. Current opportunistic infection requiring parenteral therapy 3. Any formal contraindication to receive the study drugs 4. Current treatment with investigational drugs |
| Date of first enrolment | 15/04/2003 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Spain
Study participating centre
Infectious Diseases and HIV Unit
Barcelona
08036
Spain
08036
Spain
Sponsor information
Sponsor not yet defined (Spain)
Not defined
Not defined
Infectious Diseases and HIV Unit
Hospital Clinic
Villarroel 170
Barcelona
08036
Spain
| Phone | +34 (0)932275430 |
|---|---|
| gatell@medicina.ub.es |
Funders
Funder type
Industry
GlaxoSmithKline (GSK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
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 |
