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3. Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials

Author

Eron, Joseph J, Cooper, David A, Steigbigel, Roy T, Clotet, Bonaventura, Gatell, Jose M, Kumar, Princy N, Rockstroh, Jurgen K, Schechter, Mauro, Markowitz, Martin, Yeni, Patrick, Loutfy, Mona R, Lazzarin, Adriano, Lennox, Jeffrey L, Strohmaier, Kim M, Wan, Hong, Barnard, Richard JO, Nguyen, Bach-Yen T, and Teppler, Hedy

Published
2013
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11. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 phase III trials

Author

Steigbigel, Roy T., Cooper, David A., Teppler, Hedy, Eron, Joseph J., Gatell, Jose M., Kumar, Princy N., Rockstroh, Jurgen K., Schechter, Mauro, Katlama, Christine, Markowitz, Martin, Yeni, Patrick, Loutfy, Mona R., Lazzarin, Adriano, Lennox, Jeffrey L., Clotet, Bonaventura, Zhao, Jing, Wan, Hong, Rhodes, Rand R., Strohmaier, Kim M., Barnard, Richard J., Isaacs, Robin D., and Nguyen, Bach-Yen T.

Subjects
Raltegravir -- Dosage and administration, Raltegravir -- Research, HIV infection -- Drug therapy, HIV infection -- Research, Drug resistance -- Research, Clinical trials -- Research, Creatine kinase -- Physiological aspects, Creatine kinase -- Research, Health, Health care industry
Published
2010

12. Raltegravir with optimized background therapy for resistant HIV-1 infection

Author

Steigbigel, Roy T., Cooper, David A., Kumar, Princy N., Eron, Joseph E., Schechter, Mauro, Markowitz, Martin, Loutfy, Mona R., Lennox, Jeffrey L., Gatell, Jose M., Rockstroh, Jurgen K., Katlama, Christine, Yeni, Patrick, Lazzarin, Adriano, Clotet, Bonaventura, Jing Zhao, Chen, Joshua, Ryan, Desmond M., Rhodes, Rand R., Killar, John A., Gilde, Lucinda R., Strohmaier, Kim M., Meibohm, Anne R., Miller, Michael D., Hazuda, Daria J., Nessly, Michael L., DiNubile, Mark J., Isaacs, Robin D., Nguyen, Bach-Yen, and Teppler, Hedy

Subjects
HIV patients -- Care and treatment, Placebos -- Evaluation, Raltegravir -- Evaluation
Abstract

The efficacy of Raltegravir in combination with optimized background therapy for patients infected with HIV-1 in whom antiretroviral therapy had failed is evaluated. Results indicated that this combination of Raltegravir with optimized background therapy was more effective than plain optimized background therapy alone.

Published
2008

13. Subgroup and resistance analyses of Raltegravir for resistant HIV-1 infection

Author

Cooper, David A., Steigbigel, Roy T., Gatell, Jose M., Rockstroh, Jurgen K., Katlama, Christine, Yeni, Patrick, Lazzarin, Adriano, Clotet, Bonaventura, Kumar, Princy N., Eron, Joseph E., Schechter, Mauro, Markowitz, Martin, Loutfy, Mona R., Lennox, Jeffrey L., Jing Zhao, Chen, Joshua, Ryan, Desmond M., Rhodes, Rand R., Killar, John A., Gilde, Lucinda R., Strohmaier, Kim M., Meibohm, Anne R., Miller, Michael D., Hazuda, Daria J., Nessly, Michael L., DiNubile, Mark J., Isaacs, Robin D., Teppler, Hedy, and Nguyen, Bach-Yen

Subjects
HIV patients -- Care and treatment, Drug resistance in microorganisms -- Analysis, Placebos -- Evaluation, Raltegravir -- Evaluation
Abstract

The efficacy of raltegravir and the development of viral resistance in two trials in patients infected with HIV-1 in whom antiretroviral therapy has failed are presented. The results indicated that in both trials raltegravir along with optimized background therapy was effective in patients with HIV-1.

Published
2008

14. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals

Author

Markowitz, Martin, Morales-Ramirez, Javier O., Bach-Yen Nguyen, Kovacs, Colin M., Steigbigel, Roy T., Cooper, David A., Liporace, Ralph, Schwartz, Robert, Isaacs, Robin; Gilde, Lucinda R., and Isaacs, Robin; Gilde, Lucinda R.; Wenning, Larissa

Subjects
HIV infection -- Drug therapy, Antiviral agents -- Dosage and administration, Antiviral agents -- Health aspects, Health
Abstract

A study was conducted to explore the antiretroviral activity and safety of MK-0518 versus placebo for 10 days as monotherapy in antiretroviral therapy-naive HIV-1-infected patients with plasma HIV-1 RNA levels of at least 5000 copies/mL and CD[4.sup.plus] T-cell counts of at least 100 cells/m[m.sup.3]. MK-0518 was found to reveal potent antiretroviral activity as short-term monotherapy and was generally well tolerated at all doses.

Published
2006

15. Improved insulin sensitivity and body fat distribution in HIV-infected patients treated with rosiglitazone: a pilot study

Author

Gelato, Marie C., Mynarcik, Dennis C., Quick, Joyce L., Steigbigel, Roy T., Fuhrer, Jack, Brathwaite, Collin E. M., Brebbia, John S., Wax, Mark R., and McNurlan, Margaret A.

Subjects
Immunological research -- Statistics, Immunological research -- Analysis, HIV patients -- Health aspects, HIV patients -- Drug therapy, HIV infection -- Prevention, HIV infection -- Research, HIV infection -- Health aspects, Insulin -- Physiological aspects, Adipose tissues -- Physiological aspects, Rosiglitazone maleate -- Physiological aspects, Rosiglitazone maleate -- Usage, Thiazolidinediones -- Usage, Thiazolidinediones -- Physiological aspects, Drug resistance -- Research, Health
Abstract

Research has been conducted on the insulin-sensitizing drugs hiazolidinediones, including rosiglitazone which improve insulin sensitivity. The hypothesis that these drugs can help HIV-infected patients to improve insulin sensitivity and body fat distribution via increasing periferal fat has been tested and the results are reported.

Published
2002

17. Association of severe insulin resistance with both loss of limb fat and elevated serum tumor necrosis factor receptors levels in HIV lipodystrophy

Author

Mynarcik, Dennis C., McNurlan, Margaret A., Steigbigel, Roy T., Fuhrer, Jack, and Gelato, Marie C.

Subjects
Lipid metabolism disorders -- Research, Protease inhibitors -- Adverse and side effects, Insulin resistance -- Causes of, HIV patients -- Physiological aspects, Health
Abstract

The abnormalities in body fat distribution seen in HIV patients taking protease inhibitors seems to be caused by some type of inflammatory process. These patients also develop insulin resistance, but it appears to be different than the insulin resistance seen in diabetics and obese people.

Published
2000

19. Insulin-like growth factor system in patients with HIV infection: effect of exogenous growth hormone administration

Author

Mynarcik, Dennis C., Frost, Robert A., Lang, Charles H., DeCristofaro, Kim, McNurlan, Margaret A., Garlick, Peter J., Steigbigel, Roy T., Fuhrer, Jack, Ahnn, Sang, and Gelato, Marie C.

Subjects
Somatotropin -- Physiological aspects, Wasting syndrome -- Physiological aspects, HIV infection -- Care and treatment, Health
Abstract

Growth hormone increases blood levels of insulin-like growth factor-I (IGF-I) in HIV patients. Growth hormone and IGF-I control body mass, and may therefore be beneficial in patients with AIDS wasting syndrome.

Published
1999

22. A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome: AIDS Clinical Trials Group Protocol 021

Author

Hardy, W. David, Feinberg, Judith, Finkelstein, Dianne M., Power, Maureen E., He, Weili, Kaczka, Carolyn, Frame, Peter T., Holmes, Martin, Waskin, Hetty, Fass, Robert J., Powderly, William G., Steigbigel, Roy T., Zuger, Abigail, and Holzman, Robert S.

Subjects
Co-trimoxazole -- Usage, Pentamidine isethionate -- Usage, Pneumocystis carinii pneumonia -- Prevention, AIDS (Disease) -- Complications
Abstract

Trimethoprim-sulfamethoxazole may be more effective than aerosolized pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) in AIDS patients being treated with zidovudine (AZT). PCP is a common opportunistic infection among AIDS patients. Among 310 AIDS patients being treated with zidovudine who had recovered from their first episode of PCP, 154 were treated with 160 milligrams (mg) of trimethoprim and 800 mg of sulfamethoxazole once a day and 156 were treated with 300 mg of aerosolized pentamidine once every four weeks. Fourteen patients (9%) in the trimethoprim-sulfamethoxazole group developed a recurrence of PCP over an average of 18 months, compared with 36 (23%) in the pentamidine group. The average time to develop a PCP recurrence was longer for patients treated with trimethoprim-sulfamethoxazole than for those treated with pentamidine. The number of side effects that occurred was similar for individuals in both treatment groups.

Published
1992

27. Impairment of phagosome-lysosome fusion in HIV-1-infected macrophages

Author

Moorjani, Harish, Craddock, Barbara P., Morrison, Sidonie A., and Steigbigel, Roy T.

Subjects
Opportunistic infections -- Causes of, HIV infection -- Physiological aspects, Macrophages -- Physiological aspects, Health
Abstract

People infected with HIV-1 may be more susceptible to opportunistic infections when phagosome-lysosome fusion is prevented in macrophages in their blood. Phagosome-lysosome fusion is necessary for the destruction of organisms and is suppressed by some viruses. Macrophages infected in vitro with HIV-1 showed a reduction in phagosome-lysosome fusion from an average of 70% to an average of 47%. The interaction of the two glycoproteins gp 120 and CD4 is the first step in viral entry and may be the cause of abnormal phagosome-lysosome fusion.

Published
1996

28. A phase II study of recombinant human interferon-alpha2a and zidovudine in patients with AIDS-related Kaposi's sarcoma

Author

Fischl, Margaret A., Finkelstein, Dianne M., He, Weili, Powderly, William G., Triozzi, Pierre L., and Steigbigel, Roy T.

Subjects
Kaposi's sarcoma -- Drug therapy, AIDS (Disease) -- Complications, Interferon alpha -- Health aspects, Zidovudine -- Health aspects, Health
Abstract

Interferon-alpha2a administered in combination with zidovudine appears to have antitumor effects in people with AIDS-related Kaposi's sarcoma. Researchers gave moderate doses of interferon-alpha2a and zidovudine to 62 HIV-infected people with nonvisceral Kaposi's sarcoma. Treatment lasted an average of 28 weeks, and follow-up lasted an average of 49 weeks. Partial or complete antitumor responses occurred in 25 study participants. Participants entering the study with higher CD4 cell counts, and therefore a lesser extent of immune system damage, were more likely to experience an antitumor response. The antitumor response lasted an average of 22 weeks. Of the 25 participants who had responses, 4 suffered tumor relapses and 2 others died. Side effects from the drugs ranged from fever and malaise to liver toxicity. Three participants stopped taking the drugs due to side effects. The findings indicate that this combination therapy may be tolerated by patients and may be useful even to patients with low CD4 cell counts.

Published
1996

30. In situ detection of PCR-amplified HIV-1 nucleic acids in lymph nodes and peripheral blood in patients with asymptomatic HIV-1 infection and advanced-stage AIDS

Author

Nuovo, Gerard J., Becker, Joanne, Burk, Martyn W., Margiotta, Michele, Fuhrer, Jack, and Steigbigel, Roy T.

Subjects
Nucleic acids -- Measurement, Polymerase chain reaction -- Usage, HIV infection -- Development and progression, Health
Abstract

The polymerase chain reaction (PCR) can be used to identify changes in T cell distribution in HIV-infected people. Lymph node biopsies were done on 12 HIV-infected people. Six had AIDS and six were asymptomatic. Biopsies were also done on six healthy people. All participants also donated blood samples. PCR was used to increase viral DNA and RNA in the tissue samples. HIV DNA was detected in all lymph node samples from HIV-infected people but not in the healthy people. When PCR was not used, only two samples tested positive for HIV DNA. Researchers also discovered changes in the proportion of different cell types in the lymph nodes as the disease progressed. For example, CD21+ dendritic cells were the predominant cell in the lymph nodes of asymptomatic HIV-infected people, but were seldom detected in the lymph nodes of the AIDS patients.

Published
1994

38. Trimetrexate with Leucovorin versus Trimethoprim-Sulfamethoxazole for Moderate to Severe Episodes of Pneumocystis carinii Pneumonia in Patients with AIDS: A Prospective, Controlled Multicenter Investigation of the AIDS Clinical Trials Group Protocol 029/031

Author

AIDS Clinical Trials Group 029/031 Research Team, Sattler, Fred R., Frame, Peter, Davis, Roger, Nichols, Larry, Shelton, Brent, Akil, Bisher, Baughman, Robert, Hughlett, Claire, Weiss, Walter, Boylen, C. Thomas, van der Horst, Charles, Black, John, Powderly, William, Steigbigel, Roy T., Leedom, John M., Masur, Henry, and Feinberg, Judith

Published
1994

39. Sorivudine versus Acyclovir for Treatment of Dermatomal Herpes Zoster in Human Immunodeficiency Virus-Infected Patients: Results from a Randomized, Controlled Clinical Trial

Author

Gnann, John W., Crumpacker, Clyde S., Lalezari, Jacob P., Smith, Jean A., Tyring, Stephen K., Baum, Kenneth F., Borucki, Michael J., Joseph, W. Patrick, Mertz, Gregory J., Steigbigel, Roy T., Cloud, Gretchen A., Soong, Seng-jaw, Sherrill, Lanette C., DeHertogh, Deborah A., Whitley, Richard J., and Group, the Collaborative Antiviral Study Group (Casg)/aids Clinical Trials Group (Actg) Herpes Zoster Study

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Acyclovir, Placebo, Antiviral Agents, Herpes Zoster, law.invention, Double-Blind Method, Randomized controlled trial, Recurrence, law, Internal medicine, medicine, Humans, Pharmacology (medical), Aciclovir, Adverse effect, Aged, Pharmacology, Univariate analysis, AIDS-Related Opportunistic Infections, business.industry, Viral culture, Arabinofuranosyluracil, virus diseases, Middle Aged, Surgery, Treatment Outcome, Infectious Diseases, Tolerability, Quality of Life, Female, business, Sorivudine, medicine.drug
Abstract

The present randomized, double-blind, placebo-controlled, multicenter clinical trial was designed to compare the efficacy and tolerability of sorivudine [1-β- d -arabinofuranosyl-E-(2-bromovinyl)uracil] and acyclovir for the treatment of dermatomal herpes zoster in human immunodeficiency virus (HIV)-seropositive patients. A total of 170 HIV-seropositive adults presenting with herpes zoster (confirmed by direct fluorescent-antigen testing and/or viral culture) were enrolled and randomized to receive a 10-day course of orally administered sorivudine (40 mg once daily plus acyclovir placebos) or acyclovir (800 mg five times daily plus sorivudine placebo). Patients were monitored daily to document the events of cutaneous healing, pain, zoster-related complications, and drug-related adverse events. Patients were reassessed on days 21 and 28 and then once monthly for 1 year. The primary efficacy endpoint was time to the cessation of new vesicle formation. Secondary efficacy endpoints included times to other events of cutaneous healing, resolution of pain, and frequency of dissemination and zoster recurrence. In a multivariate analysis, sorivudine was superior to acyclovir for reducing the times to the cessation of new vesicle formation (relative risk [RR] = 1.54, 95% confidence interval [CI] = 1.00 to 2.36; P = 0.049) and total lesion crusting (RR = 1.48, 95% CI = 1.07 to 2.04; P = 0.017). In a univariate analysis, there was a trend favoring sorivudine for the cessation of new vesicle formation (median of 3 versus 4 days; P = 0.07) and a significant advantage for time to total lesion crusting (median of 7 versus 8 days; P = 0.02). The time to the resolution of zoster-associated pain, the frequency of dissemination, and the frequency of zoster recurrence were not different between the two treatment groups. Both drugs were well tolerated. Sorivudine is an effective drug for the treatment of herpes zoster in HIV-infected patients and results in accelerated cutaneous healing when compared with acyclovir therapy.

Published
1998
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40. Perspective: Emerging Challenges in the Treatment of Influenza and Parainfluenza in Transplant Patients

Author

Moss, Ronald B., Steigbigel, Roy T., Sanders, Rebecca L., and Fang, Fang

Subjects
Article Subject, viruses, virus diseases
Abstract

Influenza, respiratory synctial virus, and parainfluenza are common respiratory infections in immunocompromised transplant recipients, causing significant morbidity and mortality in this patient population. This paper focuses on influenza and parainfluenza virus infections in transplant patients with emphasis on the pandemic 2009 H1N1 influenza infection. Current antiviral treatment recommendations for influenza and parainfluenza in immunocompromised patients as well as novel investigational therapeutic approaches currently being tested in the clinic are discussed. In addition to the morbidity and mortality caused by these viruses, the development of multidrug resistance leading to transmission of resistant viruses is of great public health concern. The development of effective new therapies for influenza and parainfluenza in these high-risk patients is needed with randomized placebo-controlled studies to assess their clinical utility.

Published
2011
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42. Raltegravir in combination with other antiretroviral agents for the treatment of HIV infection

Author

Chirch,Lisa, Steigbigel,Roy T, Chirch,Lisa, and Steigbigel,Roy T

Abstract

Lisa M Chirch, Roy T SteigbigelDivision of Infectious Diseases, Department of Medicine, Stony Brook University Medical Center, Stony Brook, New York, USAAbstract: Raltegravir, an inhibitor of the HIV-1 integrase enzyme, is the first available agent in a new class of antiretroviral drugs. Raltegravir has been studied extensively in clinical trials, and has been well tolerated and highly effective in both treatment-naïve and -experienced patients. Resistance to raltegravir is unusual given its recent availability, but resistance with identified viral mutation pathways in the integrase gene in patients receiving the drug does occur.Keywords: raltegravir, integrase, human immunodeficiency virus, drug resistance

Published
2010

49. Varicella zoster virus transverse myelitis without cutaneous rash

Author

Heller, Howard M., Carnevale, Nicholas T., and Steigbigel, Roy T.

Subjects
Cerebrospinal fluid -- Analysis, Cutaneous manifestations of general diseases -- Evaluation, Shingles (Disease) -- Complications, Spinal cord -- Inflammation, Acyclovir -- Evaluation, Health, Health care industry
Abstract

Infection with varicella zoster virus (VZV) has been associated with various nerve complications, including inflammation of the brain, membranes in the brain and spinal cord, the spinal cord itself, and the spinal nerve roots; paralysis of half of the body; nerve pain; and nerve disorders associated with the cranium or skull. These nerve disorders are usually associated with skin rash. A case is described of a 31-year-old man with myelitis, inflammation of the spinal cord, due to VZV infection who did not develop a skin rash. The patient developed pain within the lower back and back of thighs, was unable to retain feces, and retained urine. Within the next eight days, function of his lower extremities deteriorated. The patient was treated with dexamethasone and his condition improved gradually. VZV was detected in his spinal fluid, and the patient was given the antiviral agent acyclovir. The patients was able to regain his walking ability, although his urinary retention persisted. This case shows that infection with VZV can cause nerve disease without evidence of skin rash or without triggering the production of antibodies, immune system proteins. Under such conditions, the presence of VZV may be determined by analysis of spinal fluid. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1990

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