Intermittent ART in Primary HIV Infection
Summary
Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treatment (ART) during PHI, indication of ART is still not universally recommended. The investigators randomized patients with PHI, with a favourable immunological profile and well controlled on ART, to undergone structured treatment interruptions alone or with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up to nine years since final ART stop.
Timeline
- Start
- 2000-03
- Primary completion
- 2013-04
- Completion
- 2013-04
Outcome
Missed primary endpoint
paper Only one out of 12 patients (in the STI group) maintained VL<3000 copies/mL and CD4 cells >500 cells/mm3 without ART at 48 weeks. PMID 26186440 ↗
paper CONCLUSIONS: STI and IL-2 failed to achieve virological control after ART interruption. PMID 26186440 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 750000 unknown | Subcutaneous |
| Background | INDINAVIR ANHYDROUS | Other / unclassified | — | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Stavudine | Other / unclassified | — | — |