drugset / Trial / NCT01019551
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
Phase 2
Completed
29 enrolled
Objectif Recherche Vaccins SIDA
Cytheris SA · collabMerck Sharp & Dohme LLC · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral therapy plus immunomodulation
Timeline
- Start
- 2010-09
- Primary completion
- 2012-07
- Completion
- 2013-02
Publications
- Background Murphy RL, Autran B, Katlama C, Brucker G, Debre P, Calvez V, Clotet B, Clumeck N, Costagliola D, Deeks SG, Dorrell L, Gatell J, Haase A, Klein M, Lazzarin A, McMichael AJ, Papagno L, Schacker TW, Wain-Hobson S, Walker BD, Youle M. A step ahead on the HIV collaboratory. Science. 2009 Jun 5;324(5932):1264-5. doi: 10.1126/science.324_1264b. No abstract available.
- Background Lewin SR, Rouzioux C. HIV cure and eradication: how will we get from the laboratory to effective clinical trials? AIDS. 2011 Apr 24;25(7):885-97. doi: 10.1097/QAD.0b013e3283467041.
- Background Lafeuillade A. Eliminating the HIV reservoir. Curr HIV/AIDS Rep. 2012 Jun;9(2):121-31. doi: 10.1007/s11904-012-0115-y.
- Background Cohen J. The emerging race to cure HIV infections. Science. 2011 May 13;332(6031):784-5, 787-9. doi: 10.1126/science.332.6031.784. No abstract available.
- Background Lewin SR, Evans VA, Elliott JH, Spire B, Chomont N. Finding a cure for HIV: will it ever be achievable? J Int AIDS Soc. 2011 Jan 24;14:4. doi: 10.1186/1758-2652-14-4.
- Katlama C, Lambert-Niclot S, Assoumou L, Papagno L, Lecardonnel F, Zoorob R, Tambussi G, Clotet B, Youle M, Achenbach CJ, Murphy RL, Calvez V, Costagliola D, Autran B; EraMune-01 study team. Treatment intensification followed by interleukin-7 reactivates HIV without reducing total HIV DNA: a randomized trial. AIDS. 2016 Jan;30(2):221-30. doi: 10.1097/QAD.0000000000000894.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Interleukin-7 | Protein / enzyme biologic | 20 ug/kg | — |
| Subject | Maraviroc | Other / unclassified | 150 mg | Oral |
| Subject | Maraviroc | Other / unclassified | 300 mg | Oral |
| Subject | Maraviroc | Other / unclassified | 600 mg | Oral |
| Subject | Raltegravir | Other / unclassified | 400 mg | Oral |