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Query: UMLS:C0019693 (
HIV
)
170,526
document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)
The US Food and Drug Administration (FDA) has approved the marketing of five new drugs for treatment of
HIV infection
. Stavudine (D4T; Zerit -- Bristol-Myers Squibb) and lamivudine (3TC; Epivir -- Glaxo Wellcome) are nucleoside analogs similar to zidovudine (AZT), didanosine (ddI) and zalcitabine (ddC). Saquinavir (Invirase -- Roche), ritonavir (
Norvir
-- Abbott) and indinavir (Crixivan -- Merck) are protease inhibitors, a new class of anti-
HIV
drugs.
...
PMID:New drugs for HIV infection. 860 77
In 1995 and 1996, the Food and Drug Administration (FDA) approved three products in the new protease inhibitor class of drugs--saquinavir (Invirase), ritonavir (
Norvir
), and indinavir (Crixivan). Another drug in this class of agents, nelfinavir (Viracept) (Agouron Pharmaceuticals), is expected to be available soon from the manufacturer through an expanded-access program. All four drugs, which inhibit
HIV
protease and thus interfere with viral maturation and replication, are the most potent antiretroviral agents available to treat patients with
HIV disease
. However, these protease inhibitors interact with rifamycin derivatives, such as rifampin and rifabutin, which are used to treat and prevent the mycobacterial infections commonly observed in
HIV
-infected patients. Rifamycins accelerate the metabolism of protease inhibitors (through induction of hepatic P450 cytochrome oxidases), resulting in subtherapeutic levels of the protease inhibitors. In addition, protease inhibitors retard the metabolism of rifamycins, resulting in increased serum levels of rifamycins and the likelihood of increased drug toxicity. This report describes approaches for managing patients who are candidates for or who are undergoing protease inhibitor therapy when tuberculosis (TB) is diagnosed and presents interim recommendations for managing these patients until additional data are available and formal guidelines are issued.
...
PMID:Clinical update: impact of HIV protease inhibitors on the treatment of HIV-infected tuberculosis patients with rifampin. 892 17
Therapeutic drug monitoring is essential in
HIV
-patients undergoing highly active antiretroviral therapy (HAART). Saquinavir (SQV) is used alone or in combination with ritonavir (RTV) or nelfinavir (NLF), respectively, in the context of the HAART drug regimen. The achievable SQV concentration range in clinical practice remains to be elucidated. A non-randomized prospecitve clinical trial 19 patients (group I) receiving SQV (1x600 mg/d Invirase or Fortovase), 29 patients (group II) receiving SQV (2x600 mg/d Fortovase) plus RTV (2x400 mg/d
Norvir
), and 21 patients (group III) receiving SQV (2x600 mg/d Fortovase) plus NLF (2x750 mg/d Viracept) was conducted to determine SQV plasma concentrations. SQV levels were determined as trough levels during routine outpatient visits. Analysis was performed by HPLC with UV detection. The lowest SQV plasma levels were found in group I (95% CI 89-177 ng/ml). Significantly higher SQV levels were found in group III (combination with NLF) ranging from 242 to 398 ng/ml (95% CI) and in group II (combination with RTV) ranging from 1354 to 1747 ng/ml (95% CI). The IC 50% of 54 ng/ml was not reached in at least one sample during the study (mean duration of study 16+/-10 months) in 14/19 patients of group I, 9/29 patients in group II and 13/21 patients in group III, respectively. A positive correlation between patient compliance, defined by SQV levels in the 95% CI of the used combination, and the
HIV
RNA plasma level was found. The presented data confirm that therapy with SQV alone may not be effective, since trough levels are near the lower limit of antiretroviral efficacy. Although the combination of SQV with NLF results in higher SQV plasma concentrations in a bid regimen, in more than 60% of the patients SQV concentrations below IC 50 level were detected during the twelve-months study period. The combination of SQV with RTV yields the highest SQV-trough levels. SQV concentrations below the IC 50 were seen in only 31% of patients with the SQV/RTV combination. In conclusion, therapeutic drug monitoring allows an efficient surveillance of patients compliance. In addition, therapeutic drug monitoring represents a valuable tool for management of HAART in patients receiving a complex comedication or suffering from advanced liver disease.
...
PMID:Therapeutic drug monitoring of saquinavir in patients during protease inhibitor therapy with saquinavir alone or in combination with ritonavir or nelfinavir. 1072 May 64
Ritonavir (
Norvir
), a protease inhibitors, was approved for
HIV
treatment by the Food and Drug Administration (FDA). Studies have shown that ritonavir helps people live longer and delays the progression of the illness. One study showed that the death rate for the treated group was half that of the group taking a placebo. Ritonavir should be taken with meals. Many people cannot tolerant the side effects, including nausea, vomiting, weakness, diarrhea, elevated liver enzymes, and numbing around the mouth. Ritonavir affects the way other drugs are absorbed by the body, and its use should be closely monitored for toxic reactions.
...
PMID:Ritonavir (Norvir). 1136 97
The recent approval of three protease inhibitors introduces a welcome element of choice into
HIV
treatment programs. Ritonavir (
Norvir
), indinavir (Crixivan), and saquinavir (Invirase) all prevent
HIV
from replicating, leading to lower viral loads and a slower disease progression. However, patients must continue taking the drugs once they begin therapy; stopping the treatment or reducing the dosage can lead to resistance. Long term data is not yet available on toxicity or drug interactions. All three drugs are most effective when used in combination therapy.
...
PMID:Freedom of choice. 1136 32
The growing chasm between therapeutic options in Europe and America is causing anger and desperation among
HIV
-infected Europeans and their physicians. Many European doctors and activists accuse Abbott Laboratories and Merck, with the help of Food and Drug Administration (FDA) decisionmaking, of being primarily committed to ensuring that the U.S. market is fully supplied with therapeutic drugs, no matter what the cost is to Europe. Both companies deny any such plans and reveal their manufacturing and supply plans for
Norvir
(Abbott) and Crixivan (Merck) for the near future in order to meet the needs of the entire AIDS community. The International Association of Physicians in AIDS Care is calling for the replacement of the expanded-access model with a global drug rationing agency which would approve and supervise the distribution of drugs for compassionate use.
...
PMID:Europeans outraged over expanded access. 1136 19
A small clinical trial testing a combination of ritonavir, or
Norvir
, and nucleoside analogs in newly infected
HIV
patients has shown that the therapy can lower the viral load to undetectable levels for up to two years. The trial, led by Dr. Martin Markowitz of the Aaron Diamond AIDS Research Center, may result in a standard of starting treatment as early as diagnosis. Studies are underway comparing newly infected patients treated with two combinations--ritonavir, zidovudine (AZT), and lamivudine (3TC) versus indinavir (Crixivan), AZT, and 3TC. The push to treat patients early increased in 1995 when Aaron Diamond researchers discovered that
HIV
begins replicating rapidly from the onset of infection. Moreover, as use of protease inhibitors gains steam, viral load testing will become an important tool for monitoring antiretroviral treatment and patient management. Studies have suggested, but not proven, that survival can be predicted by viral load. How viral load measurements will be used remains to be determined, but most researchers agree that they are useful when the burden is very high or very low.
...
PMID:Success of combination therapy drives the push for earlier treatment. 1136 40
The Food and Drug Administration (FDA) approved two new protease inhibitors--ritonavir and indinavir--for the treatment of
HIV infection
in adults. Ritonavir (
Norvir
), developed by Abbott Laboratories, received full approval for use alone or in combination with nucleoside analogue medications in patients with advanced
HIV disease
. Two encouraging studies on ritonavir are described. An ongoing phase III trial showed mortality to be 43 percent lower than for patients receiving standard therapy alone. In a separate study, untreated
HIV
-infected individuals who were given a triple combination of ritonavir plus AZT and ddC showed significant increases in CD4+ T cells counts and decreases in viral load for at least six months. Indinavir (Crixivan), developed by Merck, received accelerated approval for monotherapy and combination therapy for the treatment of
HIV infection
in adults when therapy is warranted. New data on indinavir showed decreases in levels of
HIV
in 22 out of 25 patients who had taken a triple combination of indinavir, AZT and 3TC. In another study of patients taking a combination of indinavir, ddI, and AZT, 60 percent of the patients'
HIV
levels were reduced to undetectable levels. In addition to ritonavir and indinavir, saquinavir (Invirase, Hoffmann-La Roche) is another protease inhibitor approved for use in conjunction with nucleoside analogues for the treatment of
HIV infection
.
...
PMID:Two new protease inhibitors approved by FDA. Food and Drug Administration. 1136 99
Treatment with protease inhibitors, drugs that inhibit
HIV
protease, an essential enzyme for the survival of the
HIV
virus, decreases
HIV
to undetectable levels and has generated great optimism. Although far from finding a cure, these findings are steps toward understanding
HIV
. In December 1995, the Food and Drug Administration (FDA) approved saquinavir, followed by
Norvir
and Crixivan, all of which are protease inhibitors. Although the availability of these drugs varies, efforts are being made to provide the drugs to everyone. President Bill Clinton has asked Congress to approve $52 million, a 50 percent increase for AIDS research, to assist people who need these drugs throughout the country. In Latin America, efforts have been made to approve these drugs. According to Miklos Salgo, director of virology at Hoffmann-La Roche, Brazil has been the first country in Central and South America to approve saquinavir. Other scientists are optimistic that these new drugs will arrive in Latin America within a year.
...
PMID:[New drugs, new obstacles in the fight against HIV]. 1136 89
Double protease inhibitor combinations may be effective in some AIDS patients who do not respond to or who are intolerant of routines with a single protease inhibitor, according to an in vitro study at Harvard. The most commonly used combination was ritonavir (
Norvir
) and saquinavir. The findings showed anti-
HIV
effects on strains never exposed to treatment, as well as
HIV
strains that were resistant to AZT and nucleoside analogs. Little patient data is available, but what is available seems to contradict the laboratory tests. Further research is needed to resolve the conflict.
...
PMID:Antagonism of indinavir and saquinavir confirmed. 1136 2
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