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Query: UMLS:C0019693 (HIV)
 170,526 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Data from recently announced virology studies show that monotherapy of any kind is not an adequate treatment for HIV disease. Preliminary results of AZT, ddI, ddC, and d4T and ddI combinations are examined, as are hydroxyurea and ddI combinations. Results show that combination therapies are having a positive effect on reducing viral load, reducing disease progression, and enhancing patient survivability. It is now believed that combination therapies that include a protease inhibitor are likely to become a recommended standard of care in the near future. Preliminary studies of two new drugs, BW-1592 (Glaxo Wellcome) and bis-POM PMEA (Gilead Sciences), are highlighted.
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PMID:Update on other antivirals. 1136 13

A study is seeking more than 2,000 volunteers for a phase III trial of GS 840 (also called adefovir dipivoxil, or bis-POM PMEA), to test whether the drug, taken orally once a day, can increase survival of persons with advanced HIV, and also whether it can prevent the development of CMV disease. GS 840 is known to be active against cytomegalovirus (CMV), hepatitis B, HHV6 (human herpes virus 6), Epstein-Barr virus, and to have some modest activity against HIV. In this study, participants will continue their regular antiviral treatments, and add GS 840 or placebo once a day. More information can be obtained by calling the AIDS Clinical Trials Information Service or Gilead Sciences Medical Information.
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PMID:GS 840 (adefovir dipivoxil): broad-spectrum antiviral trial, CD4 count under 100. 1136 3

DuPont Merck and Gilead Sciences are finalizing a program to make their new, experimental anti-HIV drugs available free to people who are not benefiting from other treatments. Enrollment information is included. The program includes the drugs DMP-266 and adefovir dipivoxil, and is a model for how drug companies can work together effectively to make experimental treatments available through expanded access programs. Initially, DMP-266 enrollment will be limited to 2,000 people with CD4 counts below 50 who are failing their current regimen. Adefovir will be available to 1,000 patients with CD4 counts below 50 and viral loads above 30,000. DMP-266 is a non-nucleoside reverse transcriptase inhibitor that is only taken once a day and shows great promise when used in combination with indinavir. Adefovir belongs to the nucleotide analog reverse transcriptase inhibitor class, and shows a unique resistance profile. It is also taken only once a day.
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PMID:DMP-266 and adefovir dipivoxil: 2 new AIDS drugs available to patients without treatment options. 1136 9

New anti-HIV therapy options that have improved the clinical course of HIV/AIDS have also reduced the number of HIV-infected people who meet entry criteria in new CMV drug protocols. Enrollment problems have occurred in protocols using Gilead's nucleotide analog adefovir (the oral version of PMEA), Glaxo-Wellcome's 1263W94, and Hoffmann-LaRoche's ganciclovir prodrug RS79070. Hoffmann-LaRoche and Gilead indicate that there are difficulties in finding enough CMV-positive patients. It is suspected that Glaxo's problem may be in the study design; responses have included amending the protocol entry criteria and adding trial sites, including conducting overseas trials.
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PMID:CMV trials struggle to enroll. 1136 50

Adefovir dipivoxil (Preveon), a nucleotide analog and a prodrug of PMEA, has been approved for a limited expanded access program for patients who have failed approved treatments. Earlier results from phase I/II trials reveal Preveon has modest anti-HIV activity. Preveon is active against virus that has developed resistance to AZT, 3TC, and other approved nucleoside analogs. To be eligible, patients must be at least 13 years old, failed at least two nucleoside analog reverse transcriptase inhibitors and one protease inhibitor, and within the last 2 months have had a CD4 count of 50 or less and a viral load of at least 30,000 by PCR or at least 15,000 by bDNA. The program will supply only Preveon and the L-carnitine. The AIDS community has expressed concerns about the drug's potential kidney toxicity with long-term use, a condition that becomes clinically evident usually after the first 4 months, possibly leading physicians into complacency in performing regular laboratory tests after that time. The study requires monthly urine testing, including serum creatinine, urine protein, and urine glucose. Another concern is the study's CD4 and viral load restrictions; AIDS advocates believe the restrictions do not allow physicians flexibility in their drug treatment decision-making.
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PMID:Adefovir dipivoxil (Preveon) expanded access begins. 1136 18

Although there have been great strides in AIDS research, there is no major development on the horizon that is capturing the attention of the press. However, there are significant developments being made in a number of areas. Current antiretroviral treatments are leading to declines in AIDS deaths and infections in the United States and studies are leading to a greater understanding of treatment failures and the role of compliance and adherence. Three new antiretrovirals are available in expanded access programs: abacavir (1592), efavirenz (Sustiva, DMP-266), and adefovir dipivoxil (Preveon, bis-POM PMEA). New treatment approaches will deal with restoring immune function, using vaccines to prevent HIV and opportunistic infection, and developing more antiretrovirals to combat the disease. The role of managed care and providing treatment to the uninsured and underinsured are also issues to be addressed in the coming year.
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PMID:1998 outlook: treatment; research; access. 1136 51

Gilead Sciences announced an expanded access program for its nucleotide analog adefovir (Preveon, also called GS 840 and bis-POM PMEA). The drug is taken once a day with an amino acid, and studies show a 70 percent reduction in viral loads among people who have taken other anti-HIV drugs. The program is open to people with advanced HIV disease who have failed other treatments. Volunteers must have CD4 counts of 50 or less and viral loads of at least 30,000. A telephone number is provided for further information.
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PMID:Expanded access for adefovir. 1136 77

Adefovir (Preveon) is a new compound for treating HIV infection and presents no risk for developing cross resistance. Adefovir, at 125 mg/day, has created a 0.5 log decrease in viral load in 50 percent of patients tested. At 250 mg/day, the decreases are similar. Increases in CD4+ cells are also recorded. Adverse reactions from adefovir include nausea, diarrhea, weakness, headache, and pain; slight elevations in liver enzymes were also recorded in some subjects. At the 12th week of the study, patients also experienced drops in carnitine levels by 42 percent at 125 mg/day, and 62 percent at 250 mg/day. Overall, adefovir is determined to be better tolerated at 125 mg/day with no greater benefits derived at higher doses.
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PMID:New drug, new hope. 1136 29

The trial program for adefovir dipivoxil (preveon), an anti-HIV drug, has been expanded to include individuals whose current therapies have failed and who need new treatment alternatives. Individuals can be included regardless of their CD4 T-cell counts or viral load. Adefovir has been shown to lower the viral load of hepatitis B virus. Gilead Sciences, manufacturer of adefovir, warns against the drug's possible toxic effects on the kidneys. Enrollment information is provided.
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PMID:Preveon expanded access program broadened. 1136 58

Several sessions at the 6th Conference on Retroviruses and Opportunistic Infections described the current state of pharmacology. Sessions were devoted to Zidovudine (AZT), Stavudine (d4T), and intracellular phosphorylation; the interactions between antiretrovirals and opiates; and Delavirdine (DLV) and Adefovir (ADV) interactions. Also addressed were the pharmacokinetics in patients with liver disease; the toxicities associated with Adefovir and Amprenavir (APV); and the uses of Hydroxyurea (HU).
Hopkins HIV Rep 1999 Mar
PMID:Pharmacology: a progress report. 1136 46


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