Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tenofovir · 1 trial · 1 indication
Relative potencies of two monotherapy regimens (TDF alone vs. ABC alone) compared to the dual NRTI regimen of TDF+ABC as assessed by the short-term virologic response. (Change in HIV RNA copies/mL at baseline and day 7 for monotherapy, baseline and day 49 for dual therapy.)
At day 49 of Sequence 2 a 24-hour post dose plasma sample should be collected and processed. All 7 samples from the sparse PK (time 0, 30-min, 1-hr, 2-hr, 3-hr, 6-hr and 24-hr post dose) should be sent overnight to appropriate off-site lab for analysis. Since the patient is on dual therapy and the each drug is measured in separate labs each PBMC samples should be split at each time-point with half of the samples shipped to Gilead and half shipped to USC (two separate shipments). ALL plasma samples should be sent to USC. Since samples have to be split we will need to collect double the blood for the intracellular (PBMC) PK: Blood volume (PBMC-plasma): 40 mL - each draw Blood volume (plasma only): 3 mL - each draw Blood volume: 169 mL- over 2 days Plasma NRTI and intracellular ddNTP concentrations were measured 7 days after treatment with ABC or TDF alone and were compared to levels obtained after 7 days of treatment with both drugs
At day 49 of Sequence 2 a 24-hour post dose intracellular (PBMC) should be collected and processed. All 7 samples from the sparse PK (time 0, 30-min, 1-hr, 2-hr, 3-hr, 6-hr and 24-hr post dose) should be sent overnight to appropriate off-site lab for analysis. Since the patient is on dual therapy and the each drug is measured in separate labs each PBMC samples should be split at each time-point with half of the samples shipped to Gilead and half shipped to USC (two separate shipments). ALL intracellular (PBMC) samples should be sent to USC. Since samples have to be split we will need to collect double the blood for the intracellular (PBMC) PK: Blood volume (PBMC-plasma): 40 mL - each draw Blood volume (plasma only): 3 mL - each draw Blood volume: 169 mL- over 2 days Intracellular ddNTP concentrations were measured after 7 days on monotherapy and after 7 days on dual therapy
| Arm | Type | Description |
|---|---|---|
| Tenofovir | ACTIVE_COMPARATOR | As part of this study visit, you participants will be assigned by chance to receive either TDF alone or ABC alone |
| Abacavir | ACTIVE_COMPARATOR | As part of this study visit, you participants will be assigned by chance to receive either TDF alone or ABC alone |
| Name | Type | Description |
|---|---|---|
| Tenofovir | DRUG | 300 mg once daily |
| Abacavir | DRUG | 600 mg once daily |
Inclusion Criteria: 1. HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory te...
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Tenofovir is a small molecule being studied for the treatment of HIV Infections. It is currently in Phase 2 clinical development, with one completed trial that enrolled 21 participants in the United States. The drug is being evaluated as part of an active-controlled study.
Tenofovir is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this small molecule for the treatment of HIV Infections.
Tenofovir is in Phase 2 clinical development for HIV Infections. It is an investigational drug, meaning it has not yet been approved for commercial use. One Phase 2 trial has been completed, and the drug is not currently in any active trials.
Tenofovir has one completed clinical trial registered under NCT00214890, titled "Viral Dynamics and Pharmacokinetics of Abacavir and Tenofovir." This Phase 2 study enrolled 21 adults with HIV Infections in the United States and was active-controlled, meaning participants received either Tenofovir or a comparator treatment.
No, Tenofovir is not the same as Abacavir. They are separate drugs that were studied together in a clinical trial. The trial NCT00214890 evaluated both Abacavir and Tenofovir to compare their viral dynamics and pharmacokinetics in patients with HIV Infections.