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1. Examining the evidence on the causal effect of HAART on transmission of HIV using the Bradford Hill criteria.

Author

Nosyk, Bohdan, Audoin, Bertrand, Beyrer, Chris, Cahn, Pedro, Granich, Reuben, Havlir, Diane, Katabira, Elly, Lange, Joep, Lima, Viviane D, Patterson, Thomas, Strathdee, Steffanie A, Williams, Brian, and Montaner, Julio

Subjects
Humans, HIV Infections, Treatment Outcome, Antiretroviral Therapy, Highly Active, Viral Load, Sentinel Surveillance, Incidence, Virus Replication, Research Design, Cost-Benefit Analysis, Female, Male, Randomized Controlled Trials as Topic, Prevention, Substance Misuse, Clinical Research, Clinical Trials and Supportive Activities, HIV/AIDS, Infection, Good Health and Well Being, Bradford Hill criteria, causality, HAART, HIV prevention, human immunodeficiency virus, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology
Abstract

In recent years, evidence has accumulated regarding the ability of HAART to prevent HIV transmission. Early supportive evidence was derived from observational, ecological and population-based studies. More recently, a randomized clinical trial showed that immediate use of HAART led to a 96% decrease in HIV transmission events within HIV serodiscordant heterosexual couples. However, the generalizability of the effect of HAART, and the population-level impact on HIV transmission continues to generate substantial debate. We, therefore, conducted a review of the evidence regarding the preventive effect of HAART on HIV transmission within the context of the Bradford Hill criteria for causality. Taken together, we find the accumulated evidence supporting HIV treatment as prevention meets each of the Bradford Hill criteria for causality. We conclude that the opportunity cost of inaction while waiting for additional evidence on the generalizability of effect in other risk groups is too high. Efforts should be redoubled to mobilize the financial capital and political will to optimize implementation of HIV Treatment as Prevention strategies on a wide scale.

Published
2013

4. Whither or Wither Microbicides?

Author

Grant, Robert M., Hamer, Dean, Hope, Thomas, Johnston, Rowena, Lange, Joep, Lederman, Michael M., Lieberman, Judy, Miller, Christopher J., Moore, John P., Mosier, Donald E., Richman, Douglas D., Schooley, Robert T., Springer, Marty S., Veazey, Ronald S., and Wainberg, Mark A.

Published
2008

11. GB Virus C Infection and Survival in the Amsterdam Cohort Study

Author

Stapleton, Jack T., Chaloner, Kathryn, Williams, Carolyn F., Van der Bij, Akke K., Kloosterboer, Nico, Prins, Maria, Boeser-Nunnink, Brigitte, Geskus, Ronald B., Lange, Joep M. A., Coutinho, Roel A., and Schuitemaker, Hanneke

Published
2005

27. Virologic and Immunologic Benefits of Initial Combination Therapy with Zidovudine and Zalcitabine or Didanosine Compared with Zidovudine Monotherapy

Author

Wellcome Resistance Study Collaborative Group, Schooley, Robert T., Ramirez-Ronda, Carlos, Lange, Joep M. A., Cooper, David A., Lavelle, James, Lefkowitz, Lewis, Moore, Mark, Larder, Brendan A., St. Clair, Marty, Mulder, Jan Willem, McKinnis, Ray, Pennington, Kevin N., Harrigan, P. Richard, Kinghorn, Ian, Steel, Helen, and Rooney, James F.

Published
1996

28. The spread, treatment, and prevention of HIV-1: evolution of a global pandemic

Author

Cohen, Myron S., Hellmann, Nick, Levy, Jay A., DeCock, Kevin, and Lange, Joep

Subjects
Company distribution practices, HIV infection -- Drug therapy, HIV infection -- Prevention, HIV infection -- Statistics, HIV infection -- Distribution, Epidemics -- United States, Epidemics -- Prevention
Abstract

The most up-to-date estimates demonstrate very heterogeneous spread of HIV-1, and more than 30 million people are now living with HIV-1 infection, most of them in sub-Saharan Africa. The efficiency of transmission of HIV-1 depends primarily on the concentration of the virus in the infectious host. Although treatment with antiviral agents has proven a very effective way to improve the health and survival of infected individuals, as we discuss here, the epidemic will continue to grow unless greatly improved prevention strategies can be developed and implemented. No prophylactic vaccine is on the horizon. However, several behavioral and structural strategies have made a difference--male circumcision provides substantial protection from sexually transmitted diseases, including HIV-1, and the application of antiretroviral agents for prevention holds great promise., Introduction Now, 28 years after AIDS was first recognized (1), HIV-1 requires continued global focus and investment. The cumulative total of individuals infected with HIV-1 and deaths due to AIDS [...]

Published
2008

29. CD4 cell counts of 800 cells/m[m.sup.3] or greater after 7 years of highly active antiretroviral therapy are feasible in most patients starting with 350 cells/m[m.sup.3] or greater

Author

Gras, Luuk, Kesselring, Anouk M., Griffin, James T., Sighem. Ard I. van, Fraser, Christophe, Ghani, Azra C., Miedema, Frank, Reiss, Peter, Lange,Joep M.A., and de Wolf, Frank

Subjects
Highly active antiretroviral therapy -- Health aspects, CD4 lymphocytes -- Research, HIV infection -- Drug therapy, Health
Abstract

The CD4 cell count changes are investigated in therapy-naive patients during 7 years of highly active antiretroviral therapy (HAART) in an observational cohort. It is concluded that restoration to CD4 cell counts mare than or equal to 800 cells/m[m.sup.3] is feasible within 7 years of HAART in most HIV patients.

Published
2007

30. Effects of active treatment discontinuation in patients with a [CD4.sup.+] T-cell nadir greater than 350 cells/[mm.sup.3]

Author

Pogany, Katalin, Vanvalkengoed, Irene G., Prins, Jan M., Nieuwkerk, Pythia T., van der Ende, Ineke, Kauffmann, Robbert H., Kroon, Frank P., Verbon, Annelies, Nievaard, Marianne F., Lange, Joep M.A., and Brinkman, Kees

Subjects
Highly active antiretroviral therapy -- Health aspects, Highly active antiretroviral therapy -- Risk factors, HIV patients -- Health aspects, Health
Abstract

The safety and efficacy of discontinuing highly active antiretroviral therapy (HAART) in HIV-1-positive patients who initiated HAART at a [CD4.sup.+] T-cell count greater than 350 cells/[mm.sup.3] are evaluated. The results have shown that there is no improvement found in the quality of life, though HAART can safely be interrupted in patients with a high CD4 T-cell nadir.

Published
2007

31. Implementation of an antiretroviral access program for HIV-1-infected individuals in resource-limited settings

Author

Sow, Papa S., Otieno, Leander F., Bissagnene, Emmanuel, Kityo, Cissy, Bennink, Ruurd, Clevenbergh, Philippe, Wit, Ferdinand W.N.M., Waalberg, Esther, Rinke de Wit, Tobias, and Lange, Joep M.

Subjects
HIV patients -- Medical examination, HIV patients -- Care and treatment, Antiviral agents -- Dosage and administration, Antiviral agents -- Complications and side effects, HIV infection -- Diagnosis, Health
Abstract

The final results of the Cohort Program to Evaluate Access to Antiretroviral Therapy and Education (CARE) initiative are described. The virologic and immunologic responses to highly active antiretroviral therapy in resource-limited African settings could be as good as in Western settings if adequate medical care, counseling, proper instruction, and education of patients and medical staff during the entire study is warranted with special care in the early phase.

Published
2007

32. Dyslipidemia in an Asian population after treatment for two years with protease inhibitor-containing regimens

Author

Kerr, Stephen J., Duncombe, Chris, Avihingsanon, Anchalee, Ananworanich, Jintanat, Boyd, Mark, Sopa, Bunruan, Medtech, B., Chuenyam, Theshinee, Cooper, David A., Lange, Joep M.A., Phanuphak, Praphan, and Ruxrungtham, Kiat

Subjects
Protease inhibitors -- Health aspects, Antiviral agents -- Health aspects, Asians -- Health aspects, HIV infection -- Care and treatment, Health, Care and treatment, Health aspects
Abstract

There are limited data about dyslipidemia in Asian patients treated with combination antiretroviral therapy. To assess the relative association of different protease-inhibitor-containing regimens with the degree of dyslipidemia, fasting lipid [...]

Published
2007

33. Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks

Author

Troittier, Benoit, Walmsley, Sharon, Reynes, Jacues, Piliero, Peter, O'Hearn, Mary, Nelson, Mark, Montaner, Julio, Lazzarin, Adriano, Lalezari, Jacob, Katlama, Christine, Henry, Keith, Cooper, David, Clotet, Bonaventura, Arasteh, Keikawus, Delfraissy, Jean-Francois, Stellbrink, Hans-Jurgen, Lange, Joep, Kuritzkes, Daniel, Eron, Joseph J., Jr., Cohen, Calvin, Kinchelow, Tosca, Bertasso, Anne, Labriola-Tompkins, Emily, Shikhman, Anna, Atkins, Belinda, Bourdeau, Laurence, Natale, Christopher, Hughes, Fiona, Jain Chung, Guimaraes, Denise, Drobnes, Claude, Bader-Weder, Silvia, DeMasi, Ralph, Smiley, Lynn, and Salgo, Miklos P.

Subjects
Antiviral agents -- Research, HIV infection -- Care and treatment, Drug therapy, Combination, Health
Abstract

The analysis of pooled safety data from the pivotal phase three T-20 Versus Optimized Background Regimen Only (TORO) trials indicates that enfuvirtide is a well-tolerated antiretroviral agent with a maintained safety profile over 48 weeks in treatment-experienced HIV-1-infected adults. It is found that the rates of other adverse agents favored enfuvirtide or were generally comparable between treatments.

Published
2005

34. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen into 1 and 2 clinical trials

Author

Nelson, Mark, Arasteh, Keikawus, Clotet, Bonaventura, Cooper, David A., Henry, Keith, Katlama, Christine, Lalezari, Jacob P., Lazzarin, Adriano, Montaner, Julio S.G., O'Hearn, Mary, Piliero, Peter J., Reynes, Jacques, Cohen, Calvin, Eron, Joseph J., Jr., Kuritzkes, Daniel R., Lange, Joep, Stellbrink, Hans-Jurgen, Delfraissy, Jean-Francois, Buss, Neil E., Donatacci, Lucille, Wat, Cynthia, Gulmaraes, Denise, Demasi, Ralph, Jain Chung, and Salgo, Miklos P.

Subjects
Antiviral agents -- Research, Antiviral agents -- Licensing, certification and accreditation, HIV infection -- Drug therapy, Health
Abstract

Exploratory analyses to compare treatment effects between the enfuvirtide and control groups by different factors after 48 weeks that were carried out are discussed. It was demonstrated that the efficacy to enfuvirtide is durable plus optimized background over 48 weeks.

Published
2005

35. Plasma HIV-1 RNA decline within the first two weeks of treatment is comparable for nevirapine, efavirenz, or both drugs combined and is not predictive of long-term virologic efficacy: A 2NN substudy

Author

Leth, Frank van, Huisamen, Casper B., Wit, Ferdinand W. N. M., Badaro, Roberto, Lange, Joep M. A., Hall, David B., Vandercam, Bernard, Wet, Joss de, and Montaner, Julio S. G.

Subjects
Nevirapine -- Research, RNA -- Research, Health, Efavirenz (Medication) -- Research
Abstract

An interim analysis based on the data from the first 400 patients to assess possible differences in plasma HIV-1RNA (pVL) decline between the treatment groups is presented. A similar rate of initial decline of pVL for nevirapine (NVP), efavirenz (EFV), and NVP + EFV after adjusting for baseline pVL and region is shown.

Published
2005

36. Development of HIV with drug resistance after CD4 cell count-guided structured treatment interruptions in patients treated with highly active antiretroviral therapy after dual-nucleoside analogue treatment

Author

Nuesch, Reto, Ananworanich, Jintanat, Sirivichayakul, Sunee, Ubolyam, Sasiwimol, Siangphoe, Umaporn, Hill, Andrew, Cooper, David, Lange, Joep, Phanuphak, Praphan, and Ruxrungtham, Kiat

Subjects
HIV infection -- Drug therapy, Drug resistance -- Research, Antiviral agents -- Dosage and administration, Health, Health care industry
Published
2005

37. A prospective, randomized trial of structured treatment interruption for patients with chronic HIV type 1 infection

Author

Cardiello, Peter G., Hassink, Elly, Ananworanich, Jintanat, Srasuebkul, Preeyaporn, Samor, Tarika, Mahanontharit, Apicha, Ruxrungtham, Kiat, Hirschel, Bernard, Lange, Joep, Phanuphak, Praphan, and Cooper, David A.

Subjects
HIV infection -- Risk factors, HIV infection -- Diagnosis, HIV infection -- Care and treatment, Antiviral agents -- Dosage and administration, Health, Health care industry
Published
2005

39. Nelfinavir plasma concentrations are low during pregnancy

Author

Nellen, Jeannine F.J.B., Schillevoort, Igor, Wit, Ferdinand W.N.M., Bergshoeff, Alina S., Godfried, Mieke H., Boer, Kees, Lange, Joep M.A., Burger, David M., and Prins, Jan M.

Subjects
Nelfinavir -- Research, HIV patients -- Research, HIV patients -- Physiological aspects, HIV patients -- Care and treatment, Health, Health care industry
Published
2004

40. Three-year durability of dual-nucleoside versus triple-nucleoside therapy in a Thai population with HIV infection

Author

Ungsedhapand, Chaiwat, Srasuebkul, Preeyaporn, Cardiello, Peter, Ruxrungtham, Kiat, Ratanasuwan, Winai, Kroon, Eugene D.M.B., Siangphoe, Umaporn, Emery, Sean, Lange, Joep M.A., Cooper, David A., Phanuphak, Praphan, Tongtalung, Metta, Juengprasert, Nittaya, and Ubolyam, Sasiwimol

Subjects
Nucleosides -- Dosage and administration, Nucleosides -- Research, HIV (Viruses) -- Drug therapy, HIV (Viruses) -- Research, Health
Abstract

The long-term immunologic and virologic efficacy of the dual- and triple-nucleoside therapy for HIV infection was compared in a retrospective analysis of two randomized clinical trials in antiretroviral-naive patients in Thailand. The triple-nucleoside therapy proved more effective in inducing a sustained virologic response than the dual-nucleoside therapy as stated.

Published
2004

41. Pharmacokinetics of indinavir/ritonavir (800/100mg) in combination with efavirenz ({600mg) in HIV-1-infected subjects

Author

Boyd, Mark A., Aarnoutse, Rob E., Ruxrungtham, Kiat, Stek, Michael, Jr, Heeswijk, Rolf P. G. van, Lange, Joep M. A., Cooper, David A., Phanuphak, Praphan, and Burger, David M.

Subjects
Patients -- Research, Indinavir -- Research, Pharmacokinetics -- Research, Health
Abstract

Efavirenz (600mg) is added to indinavir/ritonavir (800/100mg) results in significant decreases in indinavir levels in healthy volunteers. The combination of indinavir/ritonavir (800/100mg) bid and efavirenz at 600mg results in adequate minimum concentrations of both indinavir and efavirenz for treating native patients.

Published
2003

44. Pharmacokinetics of once-daily saquinavir hard-gelatin capsules and saquinavir soft-gelatin capsules boosted with ritonavir in HIV-1-infected subjects

Author

Cardiello, Peter G., Monhaphol, Tarkika, Mahanontharit, Apicha, Heeswijk, Rolf P. van, Burger, David, Hill, Andrew, Ruxrungtham, Kiat, Lange, Joep M., Cooper, David A., and Phanuphak, Praphan

Subjects
Saquinavir -- Research, HIV infection -- Research, HIV infection -- Care and treatment, Pharmacokinetics -- Research, Health
Published
2003

46. Viral replication under combination antiretroviral therapy: a comparison of four different regimens

Author

Ghani, Azra C., Ferguson, Neil M., Fraser, Christophe, Donnelly, Christl A., Danner, Sven, Reiss, Peter, Lange, Joep, Goudsmit, Jaap, Anderson, Roy M., and De Wolf, Frank

Subjects
HIV infection -- Drug therapy, Anti-HIV agents -- Evaluation, Health
Abstract

A group of drugs called non-nucleoside reverse transcriptase inhibitors and drug combinations that contain these drugs are most effective at suppressing the virus, according to a study of 43 HIV patients. Nucleoside reverse transcriptase inhibitors such as zidovudine and lamivudine were least effective at suppressing the virus.

Published
2002

47. Simplifying protease inhibitor therapy with once-daily dosing of saquinavir soft-gelatin capsules/ritonavir (1600/100 mg): HIVNAT 001.3 study

Author

Cardiello, Peter G., Heeswijk, Rolf P. van, Hassink, Elly A., Srasuebkul, Preeyaporn, Mahanontharit, Apicha, Samor, Tarika M., Worarien, Wassana, Beijnen, Jos H., Hoetelmans, Richard M., Ruxrungtham, Kiat, Cooper, David A., Lange, Joep M., and Phanuphak, Praphan

Subjects
Saquinavir -- Dosage and administration, Ritonavir -- Dosage and administration, HIV infection -- Drug therapy, Health
Abstract

A capsule containing the AIDS drugs saquinavir and ritonavir that can be taken once a day is effective in suppressing viral reproduction and improving immune function, according to a study of 69 patients. Giving AIDS patients fewer pills to take may improve their compliance with treatment.

Published
2002

48. Dose-escalating study of the safety and pharmacokinetics of nelfinavir in HIV-exposed neonates

Author

Rongkavilit, Chokechai, Heeswijk, Rolf P.G. van, Limpongsanurak, Sompop, Thaithumyanon, Pimolrat, Boonrod, Chantana, Hassink, Elly A.M., Srigritsanapol, Aeumporn, Chuenyam, Theshinee, Ubolyam, Sasiwimol, Hoetelmans, Richard M.W., Ruxrungtham, Kiat, Lange, Joep M.A., Cooper, David A., and Phanuphak, Praphan

Subjects
Nelfinavir -- Dosage and administration, HIV infection in children -- Drug therapy, Health
Abstract

Doctors should monitor the dosage of nelfinavir in HIV-infected babies on a regular basis, according to a study of 22 babies less than four weeks of age. The dose may need to be adjusted frequently to maintain adequate blood levels of the drug.

Published
2002

49. Steady-state pharmacokinetics of twice-daily dosing of saquinavir plus ritonavir in HIV-1-infected individuals

Author

Veldkamp, Agnes I., Heeswijk, Rolf P.G. van, Mulder, Jan W., Meenhorst, Pieter L., Schreij, Gerrit, Geest, Siebe van der, Lange, Joep M.A., Beijnen, Jos H., and Hoetelmans, Richard M.W.

Subjects
HIV infection -- Drug therapy, Saquinavir -- Dosage and administration, Ritonavir -- Dosage and administration, Health
Abstract

Giving HIV patients 1,000 milligrams (mg) of saquinavir in combination with 100 mg of ritonavir leads to greater blood levels of saquinavir than the traditional doses of 400 mg each. In addition, the lower dose of ritonavir caused fewer side effects.

Published
2001

50. Antiretroviral treatment simplification witih nevirapine in protease-inhibitor-experienced patients with HIV-associated lipodystrophy: 1-year prospective follow-up of a multicenter, randomized, controlled study

Author

Ruiz, Lidia, Negredo, Eugenia, Domingo, Pere, Paredes, Roger, Francia, Esther, Balague, Montserrat, Gel, Silvia, Bonjoch, Anna, Fumaz, Carmina R., Johnston, Susan, Romeu, Joan, Lange, Joep, and Clotet, Bonaventura

Subjects
Lipid metabolism disorders -- Prognosis, HIV infection -- Drug therapy, Nevirapine -- Evaluation, Health
Abstract

Switching AIDS therapy from a combination of drugs that includes a protease inhibitor to one that includes nevirapine may benefit HIV patients with fat metabolism disorders caused by protease inhibitors. In a study of 106 HIV patients who switched, cholesterol levels decreased, but changes in body composition remained the same.

Published
2001

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