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Zidovudine Clinical Trials

Differences in Malaria Infection Levels in HIV-infected Infants and Children Receiving PI- and NNRTI-based HAART
More than 1.5 million deaths of African children under 5 years of age have been due to Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance each other's progression. The primary purpose of this study is to compare the [more...]  malarial infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART).
Status: Recruiting Start Date: December 2009 Completion Date: 
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Women
This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study [more...]  is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria.
Status: Recruiting Start Date: December 2009 Completion Date: July 2014
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Populations Using Formula Feeding (PROMISE)
The purpose of the PROMISE study is to examine effective methods of preventing the transmission of HIV from mother to child during pregnancy, labor and delivery, and breastfeeding. Study researchers will also evaluate ways to promote positive health outcomes [more...]  in mothers and their children. The formula feeding (FF) version of the PROMISE study is intended for those study sites where a limited antiretroviral regimen after birth and formula feeding for infants are standard. The FF version of the PROMISE study will focus on answering two research questions: (1) What is the best intervention for preventing passage of HIV from a mother to her fetus before birth and while the baby is being born? (2) What is the best intervention for preserving the mother's health after the risk period for mother-to-child transmission of HIV has passed?
Status: Recruiting Start Date:  Completion Date: 
Antiviral Responses to a Nevirapine-Based Regimen Versus a Lopinavir/Ritonavir-Based Regimen in HIV Infected Infants Who Have or Have Not Received Single Dose Nevirapine for the Prevention of Mother-to-Child Transmission of HIV
A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has shown to be an effective way of reducing the rate of mother-to-child transmission (MTCT) of HIV. The purpose of [more...]  this study is to compare the effectiveness of a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants who have or have not been exposed to SD NVP.
Status: Recruiting Start Date: September 2006 Completion Date: October 2010
Botswana Diarrheal Diseases Study
The goals of this study are to: 1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers and 2. link analysis of the [more...]  functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.
Status: Recruiting Start Date:  Completion Date: 
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-Term Observational Study
Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is [more...]  an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
Status: Recruiting Start Date: January 2002 Completion Date: December 2016
Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults
Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study is to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected [more...]  participants. These participants will have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and will be starting a protease inhibitor (PI)-based HAART regimen.
Status: Recruiting Start Date: March 2009 Completion Date: June 2012
Antiretroviral Therapy With or Without Bortezomib or Combination Chemotherapy and Rituximab or Sirolimus Only or Observation Only in Treating Patients With Castleman's Disease
RATIONALE: Kaposi's sarcoma-associated herpesvirus (KSHV) can cause several kinds of cancer and lymphoproliferative disorders, including some forms of Castleman's disease. Antiviral drugs such as zidovudine and valganciclovir act against KSHV. Bortezomib may make virus cells more sensitive to zidovudine [more...]  and valganciclovir. Combining zidovudine and valganciclovir with or without bortezomib may kill more KSHV cells and may be an effective treatment for KSHV-associated Castleman's disease. Alternatively, the use of combination chemotherapy and monoclonal antibody therapy using rituximab or sirolimus alone may be effective in treating patients who have life-threatening KSHV-associated Castleman's disease. PURPOSE: Clinical trial to study the effectiveness of antiretroviral therapy with or without bortezomib or combination chemotherapy and rituximab or sirolimus only or observation only in treating patients who have KSHV-associated Castleman's disease.
Status: Recruiting Start Date: September 2004 Completion Date: 
Zidovudine, Interferon Alfa-2b, and PEG-Interferon Alfa-2b in Treating Patients With Human T-Cell Lymphotropic Virus Type 1-Associated Adult T-Cell Leukemia/Lymphoma
RATIONALE: Human T-cell lymphotropic virus type 1 can cause cancer. Zidovudine is an antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune system and [more...]  slow down or keep the cancer cell from growing. PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic virus type 1-associated adult T-cell leukemia/lymphoma.
Status: Recruiting Start Date: November 2007 Completion Date: 
Study of Options for Second-Line Effective Combination Therapy (SELECT)
The study is being done with people who are taking their first anti-HIV drug regimen (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV drug) but the drugs in this regimen are not doing a good job of fighting their HIV [more...]  infection. The main purpose of this study is to compare two other anti-HIV drug regimens to see how well they fight HIV. The study will also see how well participants tolerate the drug regimens and how safe they are. The study will determine whether taking the combination of lopinavir/ritonavir (LPV/r) plus raltegravir (RAL) works as well as what usually is used for second-line therapy: LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI) combination. Testing a regimen that does not include any NRTI is important because NRTIs may no longer work for patients who received them as part of their first treatment regimen.
Status: Not yet recruiting Start Date: June 2011 Completion Date: January 2015
When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)
The purpose of this study is to determine when HIV infected children should begin taking anti-HIV medications in order to improve both patient quality of life and survival.
Status: Active, not recruiting Start Date: March 2006 Completion Date: 
Maternal and Infant Peripartum Nevirapine, Versus Infant Only Peripartum Nevirapine, or Maternal Lopinavir/Ritonavir in Addition to Standard Zidovudine Prophylaxis for the Prevention of Perinatal HIV in Thailand
The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses to the infants, in [more...]  addition to zidovudine (ZDV) prophylaxis (from 28 weeks' gestation and for one week of ZDV in neonates) for the prevention of mother-to-child transmission of HIV-1.
Status: Active, not recruiting Start Date: July 2008 Completion Date: June 2013
Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
The purpose of this study is to see if the multidrug combination of zidovudine (ZDV), lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in [more...]  blood and other tissues. HIV infection is a life-changing illness and new HIV treatments must be tested. This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated. Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period.
Status: Active, not recruiting Start Date:  Completion Date: 
A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment
The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment. Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by [more...]  giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.
Status: Active, not recruiting Start Date:  Completion Date: 
Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
The purpose of this study is to compare two drugs (nelfinavir [NFV] and efavirenz [EFV]) used in start-up anti-HIV treatment. Doctors want to see if one is better than the other in extending the time that viral load (level of HIV in the [more...]  blood) is kept low. The study will also look at the response of the immune system to each drug.
Status: Active, not recruiting Start Date: December 1999 Completion Date: 
A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants
The purpose of this study is to determine if a combination anti-HIV drug treatment regimen of indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in reducing the chances of passing HIV from mother to child. This study will also [more...]  examine if this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC plus ZDV is safe for newborns. Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs in this study may be more effective than ZDV alone.
Status: Active, not recruiting Start Date:  Completion Date: 
Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating [more...]  patients with HIV-related non-Hodgkin's lymphoma that has relapsed or has not responded to chemotherapy.
Status: Active, not recruiting Start Date: June 1995 Completion Date: 
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection. New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected [more...]  to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.
Status: Active, not recruiting Start Date:  Completion Date: 
Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth
The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth.
Status: Active, not recruiting Start Date: July 2005 Completion Date: 
HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)
This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (PI) containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, [more...]  who are starting therapy for the first time.
Status: Active, not recruiting Start Date: February 2003 Completion Date: December 2006
Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well [more...]  giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma.
Status: Active, not recruiting Start Date: May 1997 Completion Date: 
A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT. [more...]  Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
Status: Active, not recruiting Start Date:  Completion Date: 
A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of [more...]  oral ZDV in this population, defined as the ability to take oral doses and lack of vomiting within 30 minutes of receiving oral study doses. The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that, at minimum, will approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would enable women to start an intensive ZDV regimen during early labor, even prior to reaching the hospital.
Status: Active, not recruiting Start Date:  Completion Date: 
A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. [more...]  ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
Status: Active, not recruiting Start Date:  Completion Date: 
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and [more...]  lopinavir/ritonavir (LPV/r) will also be studied. Study hypothesis: NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy (ART).
Status: Active, not recruiting Start Date: June 2006 Completion Date: 
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

Zidovudine Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Zidovudine. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Zidovudine studies are federally regulated with strict guidelines to protect patients.

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