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HIV Infections clinical trials

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NCT ID: NCT00666055 Completed - HIV Infections Clinical Trials

Sex, Aging and Antiretroviral Pharmacokinetics

Start date: March 2008
Phase: N/A
Study type: Observational

The purpose of this research study is to learn about levels of antiretroviral drug levels and response to HIV virus in the genital tract of women who are post-menopausal. The investigators in this study think that the levels of hormones post-menopausal HIV-infected women may have in their bodies may affect the levels of antiretroviral drug, and therefore affect how much HIV virus they have in their bodies. Since women who have already gone through menopause have different levels of hormones, such as estrogen, than women who are pre-menopausal, the investigators would like to check the levels of antiretroviral drugs in their blood, their genital secretions, and their genital tissue.

NCT ID: NCT00665951 Completed - HIV Infections Clinical Trials

Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)

SURF
Start date: September 2008
Phase: Phase 1
Study type: Interventional

This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded formulation. The formal bioequivalence study with adequate power will be conducted by the manufacturer. In order to get data independently from the manufacturer and to have this information in an earlier phase, this small pilot study is initiated. The initial study showed a declined bioavailability of the granules under fasting conditions. The study has been extended with an arm determining the pharmacokinetics of the granules after food (compared to the oral solution taken with food).

NCT ID: NCT00665717 Completed - HIV Infections Clinical Trials

The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

GRAPPA
Start date: May 2008
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.

NCT ID: NCT00665561 Completed - Clinical trials for Human Immunodeficiency Virus

Prospective Observational Epidemiologic Study of Maraviroc's Safety

POEM
Start date: March 31, 2008
Phase:
Study type: Observational

The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

NCT ID: NCT00663234 Completed - HIV Infections Clinical Trials

IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia

Start date: August 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of HIV with antiretroviral regimens that include protease inhibitors (PIs) frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with PIs has been associated with significant increases in cholesterol and triglycerides in HIV infected adults and children. The purpose of this study is to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV infected children receiving antiretroviral regimens containing at least one PI.

NCT ID: NCT00662545 Completed - HIV Infections Clinical Trials

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

Start date: April 2008
Phase: Phase 4
Study type: Interventional

This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination with emtricitabine or lamivudine. Eligible participants will be randomized to receive 24 weeks of entecavir (ETV) 1 mg versus continued standard of care antiretroviral therapy. After 24 weeks, individuals on entecavir or who remain HBV viremic on standard of care will receive ETV o for an additional 24 weeks. The hypothesis is that intensification with entecavir will reduce HBV DNA at 24 weeks more than continued antiretroviral therapy without entecavir.

NCT ID: NCT00662194 Recruiting - HIV Infections Clinical Trials

Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)

Start date: April 2008
Phase: N/A
Study type: Observational

Data from this study will provide the first information how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy.

NCT ID: NCT00662181 Not yet recruiting - HIV Infections Clinical Trials

Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone

Start date: May 2008
Phase: N/A
Study type: Observational

A follow-up study on the randomized, controlled, double-blind HIGH: low study. We will examine the participants from the HIGH: low study min. 6 months after finishing the HIGH: low study. We will look at the parameters: quality of life, sugar-metabolism, fat-metabolism, fat-redistribution and cytokines. The study will use the participants control visit, and the only additional examination will be the danish MOS-HIV questionnaire.

NCT ID: NCT00662077 Withdrawn - HIV Infections Clinical Trials

Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

Start date: n/a
Phase: Phase 4
Study type: Interventional

This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has already been proved.

NCT ID: NCT00661960 Completed - HIV Infections Clinical Trials

Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy

Start date: March 2008
Phase: N/A
Study type: Interventional

This research is being done to study how the immune system in the small intestine improves after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the increase in the numbers of immune cells in the intestine to see if one type of HIV medication gives different results than other types of HIV medications.