Conditions: HIV
Keywords: Pharmacokinetics antiretroviral therapy nucleoside analogs mitochondrial toxicity clinical pharmacology cellular pharmacology pharmacogenetics
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: yes

Brief summary:
This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection. Additionally, markers of side effects were correlated with blood levels of the drugs. The hypothesis was that women and those with HIV would have higher drug levels, as well as markers of side effects.

Detailed description:

Arms:
arm 1: This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women. arm 2: This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.

Interventions: intervention 1: zidovudine 300mg and lamivudine 150mg as Combivir
Intervention descriptions: intervention 1: twice daily for 12 days in the HIV-negative group and indefinitely for their care in the HIV-positive group

Protocol document: