Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00035893 | The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART | PHASE2 | COMPLETED | 40 | — | — | May 1, 2001 | Aug 1, 2006 | Apr 17, 2013 | 10 | United States |
To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.
| Arm | Type | Description |
|---|---|---|
| Ampligen | EXPERIMENTAL | Ampligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks. |
| No Ampligen | NO_INTERVENTION | No Ampligen administered for first 64 weeks |
| Name | Type | Description |
|---|---|---|
| poly I-poly C12U | DRUG | 200-400 mg IV infusions 2x/week for 64 weeks |
1. Adults at least 18 years of age. 2. CD4 cell count of \> 400 cells. 3. Plasma HIV-1 RNA \< 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline. 4. History of virologic success with suppression of HIV RNA level \< 50 copies/ml during the...