View clinical trials related to HIV-1.
Filter by:The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.
This study will test whether two experimental HIV vaccines are safe and whether they cause any side effects in healthy adults. It will examine the body s immune response to the vaccines and monitor the social impact, if any, of being in an HIV vaccine study. The experimental vaccines in this study are the VRC-HIVADV027-00-VP (also called the rAd35-EnvA vaccine) and VRC-HIVADV038-00-VP (also called the rAd5-EnvA vaccine). The vaccines are made using an adenovirus (virus that normally causes respiratory infections and colds) that has been modified to contain DNA that codes for HIV proteins. The vaccines cannot cause HIV or adenoviral infections. Healthy normal volunteers between 18 and 50 years of age may be eligible for this 2-part study. Part 1 includes 15 people. Part 2 includes 20 people. Part 1 participants receive only the rAd35-EnvA vaccine. The first five people enrolled receive the lowest study dose of the vaccine. If this dose is safe, then the next five people enrolled receive a higher dose. If this dose is safe, then the last 5 people enrolled receive the highest study dose. Subjects in Part I have about five clinic visits over 24 weeks. Part II of the study starts after all injections in Part 1 are given. Subjects in Part 2 are randomly assigned to one of two vaccination schedules. One group receives the rAd35-EnvA vaccine first, followed 12 weeks later with the rAd5-EnvA vaccine. The other group receives the vaccines in reverse order; that is, first the rAd5-EnvA vaccine, followed 12 weeks later with the rAd35-EnvA vaccine. In this schedule, the first vaccination primes the immune system and then the immune response is boosted 12 weeks later with a different vaccine. Everyone in study Part 2 receives the rAd35-EnvA vaccine at the middle dose tested in Part 1. Subjects in Part 2 have about eight clinic visits over 36 weeks. All vaccinations are given as injections in the upper arm. At each clinic visit, participants are checked for health changes or problems. They are asked how they are feeling and if they have taken any medications. Urine samples are collected and blood is drawn at some visits. They are tested for HIV several times and asked questions about their sexual behavior and drug use. Throughout the study, participants are counseled on HIV risk reduction. Subjects are asked about any social effects they may have experienced from their participation in this study.
The purpose of this randomized (patients are assigned different treatments based on chance), placebo-controlled, dose-escalating trial is to evaluate the safety, tolerability and efficacy of different doses of TMC125 twice daily ( b.i.d.) when added to an individually optimized antiretroviral therapy (ART) for 48 weeks. Dose-escalation will be performed in two stages. In the first stage approximately one hundred and eighty HIV-1 positive, three-class ART experienced patients will be randomized to placebo, 400 or 800 mg of TMC125 b.i.d. In the second stage, approximately seventy patients will be randomized to placebo, 800 or 1200 mg TMC125 b.i.d. Stage 2 will be opened for enrollment after review of the available safety and efficacy data for a specified number of patients and concurrence by the Data Safety and Monitoring Board (DSMB). After all patients are treated for a period of 12 weeks, unblinding for the sponsor will occur. The trial will continue in a single-blind fashion (sponsor unblinded, but investigator and patient blinded) for up to 48 weeks. Upon completion of the initial 48 weeks of treatment, patients deriving clinical benefit, in the opinion of the investigator, will have the option to prolong the same treatment, in a single-blind setting up to a maximum of 144 weeks.
The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and adolescents.
The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected. To be eligible, patients should be failing their current ARV regimen or be on a treatment interruption, should have previously received 2 different protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease inhibitors [PI], nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications.
A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.
This study, conducted in Tamil Nadu, India, was initiated in response to the developing epidemic of HIV/AIDS in India. It is divided into two stages, as follows: Stage I All women registered in the pregnancy clinics at the Namakkal District Hospital or the Rasipuram Government Hospital in the state of Tamil Nadu in India will be offered participation in an educational session on HIV infection and transmission. It will include a pre-educational assessment of knowledge, attitudes, and beliefs, and a post-educational assessment of knowledge about HIV infection and transmission. All women at the clinic, regardless of whether or not they participate in the educational and assessment sessions, will be offered HIV counseling and testing. The objectives of this stage of the study are to: - Assess the acceptance of education about HIV infection and transmission among pregnant women at the participating sites and their knowledge, attitudes, and beliefs about HIV - Assess the acceptance of voluntary counseling and HIV testing among pregnant women at these sites - Determine the prevalence of infection among women who accept HIV testing at these sites Stage II Pregnant HIV-infected women at the pregnancy clinics at the Namakkal District Hospital or the Rasipuram Government Hospital who are 18 years of age or older will be offered enrollment in Stage II of this study. Participants will be followed during their pregnancy and until their baby is a year old. The baby will be a part of the study from birth to one year of age. After delivery, both the mother and baby will be followed with regularly scheduled visits that include a physical examination and blood test. Treatment with the anti-AIDS drug zidovudine will be offered for both the mother and child. For the study protocol, the mother will receive the drug starting the 28th week of pregnancy and continuing through labor and delivery. The infants will start drug treatment within the first 24 hours of life and continue for 6 weeks. Women who do not choose to take zidovudine according to this schedule will be offered standard treatment with a shorter course of drug, beginning with the 36th week of pregnancy, and no preventative treatment for their infants. All women will be offered education and counseling about the risks and benefits of breastfeeding and the risk of HIV transmission through breastfeeding. The objectives of this stage of the study are to: - Assess the safety and tolerability of zidovudine given according to this protocol - Assess the acceptance of and adherence to the zidovudine regimen in the protocol - Assess the acceptance of education and counseling about breastfeeding - Determine the mother-to-child HIV transmission rates in this study - Determine the rates of illness and death through 12 months after delivery - Determine risk factors for mother-to-child transmission of HIV
This study will identify variations in the genome of the human immunodeficiency virus (HIV) early after infection and following the development of AIDS. It will analyze genetic material and clinical data from HIV-positive individuals to assess differences in viral epitopes between patients with two different gene alleles (alternative forms of a gene)-B*3501 and B*3503. (An epitope is a molecular region on the surface of an antigen capable of eliciting an immune response and of combining with the specific antibody produced by such a response.) HIV disease in people with the B*3503 allele progresses significantly faster than it does in people with the B*3501 allele. This study might provide information that is potentially useful in developing a successful HIV vaccine. Blood samples and clinical data for analysis will be obtained from the Johns Hopkins Bloomberg School of Public Health; the University of Pittsburgh; the John H. Stroger, Jr. Hospital of Cook County; the Howard Brown Health Center; Northwestern University; and the University of California at Los Angeles.
This protocol will study the clinical course of HIV-infection among volunteers who have received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and AIDSVAX B/E prior to HIV-1 infection in reference to study NCT00223080 RV144. The study will assess whether those who received the experimental vaccine combination have a slower progression of HIV disease compared to those who received the placebo injection.