HIV-1 Infection Clinical Trial
Official title:
An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate (DMPA) and Lopinavir/Ritonavir (LPV/r) and of the Effects of DMPA on Cellular Immunity and Regulation in HIV-Infected Women
This study was done to look at the level of Depo-Provera, an injectable birth control, in the blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir [LPV/r]). It is not known whether taking Depo-Provera together with Kaletra changes the amount of Kaletra in blood. Therefore, this study also looked at the levels of HIV and Kaletra before and after receiving a shot of Depo-Provera. This study evaluated the safety of Depo-Provera and Kaletra when they are used together. In addition to what is stated above, this study also explored any effect of Depo-Provera on the immune system.
The primary study objective was addressed by calculating the Area Under the
Concentration-Time Curve (AUC) from week 0 (prior to DMPA injection) to week 12 (twelve
weeks after DMPA injection) in our study participants.
DMPA was supplied and administered as part of the protocol, however Kaletra was not. It was
required that participants already be on a Kaletra based regimen prior to entering the
study, as described in the eligibility criteria.
Arm A of AIDS Clinical Trial Group (ACTG) A5093, which consisted of 14 participants who were
administered DMPA without Kaletra, was used as reference data.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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