A randomised, triple-arm study to compare the viral and immunological outcome of highly active anti-retroviral therapy during six versus 15 months versus no treatment in patients with primary human immunodeficiency virus-1 (HIV 1) infection
| ISRCTN | ISRCTN59497461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59497461 |
| Secondary identifying numbers | NTR101 |
- Submission date
- 23/02/2007
- Registration date
- 23/02/2007
- Last edited
- 16/01/2019
- 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
Prof Dr. J.M. Prins
Scientific
Scientific
Academic Medical Centre (AMC)
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 4380 |
|---|---|
| j.m.prins@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | A randomised, triple-arm study to compare the viral and immunological outcome of highly active anti-retroviral therapy during six versus 15 months versus no treatment in patients with primary human immunodeficiency virus-1 (HIV 1) infection |
| Study acronym | Primo-SHM |
| Study objectives | The aim of this study is to provide data on the effect of treatment during primary human immunodeficiency virus infection (PHI) on the viral set-point and the optimal duration of such treatment. |
| Ethics approval(s) | Approval received from the AMC Medical Ethics Committee (ref: MEC 03/059). |
| Health condition(s) or problem(s) studied | Human immunodeficiency virus (HIV), primary human immunodeficiency virus-1 (HIV-1) infection |
| Intervention | Six or 15 months of highly-active anti-retroviral therapy (HAART) initiated during primary HIV-1 infection. As of 11/08/2010 the status of this record is that inclusion to the trial has stopped and follow-up is ongoing. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Highly active anti-retroviral therapy (HAART) |
| Primary outcome measure | Plasma HIV-1 RNA at week 96: 1. Magnitude of viral set-point will be evaluated for both treatment groups 36 weeks after treatment discontinuation, and a comparison will be made between all groups at week 96 (= study end) 2. Comparison between all three groups of viral kinetics (including rebound) during the off-treatment periods |
| Secondary outcome measures | 1. CD4+ cell counts 2. Safety: (serious) adverse events, HIV related events and death 3. Quality of life 4. Time between diagnosis and start/reinitiation of HAART 5. Time between treatment discontinuation and reinitiation of HAART In selected groups/individuals: 6. HIV-1 specific CD4+ and CD8+ T-cell response and their state of activation and maturation 7. Humoral immune response parameters |
| Overall study start date | 01/05/2003 |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 173 |
| Key inclusion criteria | Diagnosis of acute/recent human immunodeficiency virus-1 (HIV-1) infection: plasma HIV-1 ribonucleic acid (RNA) load detectable and/or detectable serum p24 antigen and one of the following: 1. Enzyme-linked immunosorbent assay (ELISA): HIV-1 specific antibodies negative, or 2. ELISA: low level antibodies or HIV-1 specific antibodies positive and a negative, incomplete or indeterminate Western Blot (antibodies against a maximum of three of the HIV specific proteins), or 3. ELISA: HIV-1 specific antibodies positive and positive Western Blot, but with documented negative HIV-1 ELISA in the preceding 180 days |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/02/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Government
Dutch Government (The Netherlands)
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 | 01/09/2012 | 16/01/2019 | Yes | No |
Editorial Notes
16/01/2019: Publication reference added.
10/08/2010: This record was updated with protocol amendments; at this time, the overall trial end date was extended to 01/02/2012, the initial overall trial end date was 01/05/2006. At this time, the target number of participants was also increased from 60 to 173.
