At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infection documented by ELISA and Western blot (or alternative confirmatory test)
- ✓Antiretroviral naïve (no prior therapy)
- ✓CD4+ cell count >200 cells/mm3 within 90 days of screening
- ✓HIV-1 RNA level >5000 copies/mL within 90 days of screening
- ✕Any NRTI or NNRTI-associated resistance mutations per IAS-USA mutation list
- ✕Pregnancy and breast-feeding
- ✕Active drug or alcohol use or dependence that would interfere with adherence to study requirements
- ✕Urgent need to initiate antiretroviral therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CCTG584: Viral Dynamics and Pharmacokinetics of Tenofovir and Abacavir Monotherapy Versus the Combination Therapy of TDF-ABC in HIV-Infected Treatment Naive Patients
In Brief
A Phase 2 clinical trial evaluating Tenofovir and Abacavir for HIV Infections. Completed, enrolled 21 participants across 5 sites.
Detailed Summary
Once-daily nucleotide/nucleoside reverse transcriptase inhibitor (NtRTI/NRTI) combinations form the backbone of many regimens. Although efficacy data exists between tenofovir and the pyrimidine analogues (i.e. lamivudine and emtricitabine), recent clinical data suggests a potential interaction between tenofovir and purine analogs (i.e. abacavir and didanosine). Specific Aim 1: To evaluate the impact of an acyclic nucleoside phosphonate, tenofovir (TDF), on the intracellular metabolism of a purine nucleoside analog, abacavir (ABC), as a determinant of the antiviral potency of this nucleotide/nucleoside reverse transcriptase inhibitor (NtRTI/NRTI) combination. * Hypothesis #1: ABC and TDF dosed together will have reduced antiviral activity, as measured by early plasma HIV RNA decay kinetics, than the drugs given alone. * Hypothesis #2: ABC dosed with TDF will have reduced intracellular concentrations, as measured by the ratio of carbovir triphosphate (active metabolite of ABC) to deoxyguanosine triphosphate (endogenous nucleotide), compared to ABC given alone.
Study Details
Timeline
Interventions
300 mg once daily
600 mg once daily