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A study was conducted to quantify the change in saquinavir (SQV) and amprenavir (APV) exposure when combined and used with low-dose ritonavir and to evaluate safety and immunologic and virologic response. Further, the results revealed that protease inhibitor (PI) dosage adjustments were based on real-time pharmacokinetics assessment and that saquinavir did not affect amprenavir or ritonavir pharmacokinetics.

Taking indinavir in combination with ritonavir twice a day appears to be as effective as taking indinavir alone three times a day. Ritonavir makes indinavir last longer in the body, allowing patients to reduce the risk of side effects.

Giving HIV patients ritonavir and nelfinavir together may be beneficial, according to a study of 20 HIV patients. Both drugs are protease inhibitors and ritonavir slows the metabolism of other drugs, making them last longer in the body.

The authors note that the combination of ritonavir and saquinavir are effective in keeping viral blood count low, but that the blood-brain barrier may keep the drugs from the cerebrospinal fluid (CSF), thereby allowing a safe haven for the HIV virus. Despite many variable factors which further study might clarify, the HIV RNA levels seem equally low in CSF as in blood.

The authors tested a combination of drugs, including ritonavir, in HIV-positive children whose intestines were losing the ability to absorb nutrition. The combination restored intestinal function very quickly and the children began gaining weight and increasing their CD4 count.

Ritonavir may be effective and well-tolerated in children infected with HIV. Ritonavir is a protease inhibitor drug used to treat HIV-infected adults. Researchers evaluated the safety and effectiveness of ritonavir in 48 children, aged 6 months to 14.4 years. Ritonavir therapy resulted in an average increase in the CD4 white blood cell count of 79 cells per cubic millimeter, and a decrease in blood levels of the virus. Gastrointestinal complaints were the most common side-effects. Ritonavir may be an appropriate component of combination drug therapy in pediatric HIV disease., Background. Ritonavir, a potent antiretroviral protease inhibitor, has been approved for the treatment of adults and children with human immunodeficiency virus (HIV) infection. In a phase I/II study, we assessed the safety, tolerability, and pharmacokinetic profile of the oral solution of ritonavir in HIV-infected children and studied the preliminary antiviral and clinical effects. Methods. HIV-infected children between 6 months and 18 years of age were eligible. Four dose levels of ritonavir oral solution (250, 300, 350, and 400 mg/[m.sup.2] given every 12 hours) were evaluated in two age groups ([is less than or equal to] 2 years, [is greater than] 2 years). Ritonavir was administered alone for the first 12 weeks and then in combination with zidovudine and/or didanosine. Clinical and laboratory parameters were monitored every 2 to 4 weeks. Results. A total of 48 children (median age, 7.7 years; range, 0.5 to 14.4 years) were included in this analysis. Dose-related nausea, diarrhea, and abdominal pain were the most common toxicities and resulted in discontinuation of ritonavir in 7 children. Ritonavir was well absorbed at all dose levels, and plasma concentrations reached a peak 2 to 4 hours after a dose. CD4 cells counts increased by a median of 79 cells/[mm.sup.3] after 4 weeks of monotherapy and were maintained throughout the study. Plasma HIV RNA decreased by 1 to 2 [log.sub.10] copies/mL within 4 to 8 weeks of ritonavir monotherapy, and this level was sustained in patients enrolled at the highest dose level of 400 mg/[m.sup.2] for the 24-week period. Conclusions. The oral solution of ritonavir has potent antiretroviral activity as a single agent and is relatively well tolerated by children when administered alone or in combination with zidovudine or didanosine. Pediatrics 1998;101:335-343, protease inhibitor, child, HIV-1, CD4 cells, HIV RNA, pharmacokinetics., As of December 1996, [is greater than] 7600 children have been diagnosed with acquired immunodeficiency syndrome (AIDS) in the United States.[1] Approved treatment options for human immunodeficiency virus (HIV)-infected children [...]

Purpose of the Study. Combination anti-human immunodeficiency virus (HIV) therapy reduces viral replication and improves CD4+ T-cell counts in adults and children with HIV. Initially, changes in CD4+ cell counts involve "memory" T-cell expansions as measured by CD45RO T-cells. The objective of this study was to evaluate T-cell reconstitution after effective anti-HIV treatment of children. Methods. Forty-four HIV-infected children were treated with combination antiretroviral therapy, which included the protease inhibitor ritonavir. These were older children with a median age of 6.8 years and they had advanced disease as reflected in their Centers for Disease Control and Prevention staging. They were also naive to protease inhibitor therapy. Results. After 4 weeks of therapy, there was a significant increase in CD4+ and CD8+ T-cells. Initially, the improved CD4 + T-cell increase was seen in the "memory" subset. However, this was followed by a sustained increase in "naive" T-cells, CD45RA+ T-cells, suggesting a true immunoreconstitution and the ability to generate de novo immune responses and not just the expansion of surviving T-cell clones. Significant improvements in T-cell counts were observed even in those children whose viral load was not controlled. Conclusions. Children with advanced HIV disease have a high potential to reconstitute their CD4+ "naive" T-cells even in the face of incomplete viral suppression. Reviewer's Comment. In contrast to adults with prolonged immunosuppression secondary to HIV infection, children appear to have a unique capacity to reconstitute their T-cell functions if their virus is effectively treated. Surprisingly, effective treatment does not necessarily require complete suppression of viral replication., Sleasman JW, Nelson RP, Goodenow MM, et al. J Pediatr. 1999;134:597-606 JOSEPH A. CHURCH, MD Los Angeles, [...]