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NCT ID: NCT03708289 Terminated - HIV-1 Clinical Trials

Body Composition, Bone Health and Hormonal Status in HIV-1-infected Individuals

BONBO
Start date: September 2016
Phase:
Study type: Observational

Improved survival of people living with HIV has resulted in an increased occurrence of other comorbidities, such as cardiovascular, renal, bone and endocrine pathologies. The data that is currently available on cART-associated changes in bone mineral density, body composition and hormonal values is short-term and mainly derived from patients initiating cART in accordance with previous treatment guidelines. As current guidelines recommend earlier cART initiation and as PI-based regimens are becoming less frequently used, a favorable outcome on bone health, body composition measures and endocrine status might be expected. This study will therefore prospectively document alterations in bone mineral density, body composition and endocrine status in HIV-infected patients in whom, in the current treatment era, an INSTI-based cART regimen is initiated as a first line regimen.

NCT ID: NCT03060629 Terminated - HIV-1 Clinical Trials

A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

Start date: November 3, 2017
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.

NCT ID: NCT01345630 Terminated - HIV-1 Clinical Trials

Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

MODERN
Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

NCT ID: NCT01254656 Terminated - HIV-1 Clinical Trials

A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022

Start date: February 2011
Phase: Phase 2
Study type: Interventional

This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.

NCT ID: NCT01173276 Terminated - Infertility Clinical Trials

Intrauterine Insemination In HIV-Discordant Couples

ARTEMIS
Start date: September 2009
Phase: N/A
Study type: Interventional

This study aims to assess the feasibility of a novel standard of care technique for intrauterine insemination (IUI) in HIV-discordant couples in the United States. This study will involve couples in which the male partner is HIV positive, but the female partner is negative. The investigators will institute a protocol similar to those used presently throughout Europe with good success. To date, no HIV seroconversions have occurred in over 4000 inseminations performed in HIV serodiscordant couples. All male subjects will be on stable HAART, and have undetectable serum viral loads prior to insemination. Semen samples will be subjected to a stringent sperm wash procedure and screened for HIV RNA. Female subjects will be followed post-insemination for seroconversion and pregnancy. Infants will be followed for seroconversion at birth through 4 months of age.

NCT ID: NCT01024842 Terminated - HIV-1 Clinical Trials

Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART

Start date: December 2009
Phase: Phase 1
Study type: Interventional

In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy. MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.

NCT ID: NCT00824369 Terminated - HIV-1 Clinical Trials

A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1

Start date: July 2009
Phase: Phase 2
Study type: Interventional

The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.

NCT ID: NCT00823979 Terminated - HIV-1 Clinical Trials

A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

Start date: March 25, 2009
Phase: Phase 2
Study type: Interventional

This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral drugs and have NNRTI resistance mutations.

NCT ID: NCT00741741 Terminated - HIV-1 Clinical Trials

TMC278-TiDP15-C150: Trial to Examine Safety, Tolerability and Plasma Pharmacokinetics of Multiple Doses of TMC278LA.

Start date: July 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is: to determine the safety, (local) tolerability and plasma exposure over time of single intramuscular (IM) doses of 600 and 1200 mg of a new formulation (F006) of TMC278LA, to determine the safety, (local) tolerability and long-term plasma exposure over time of 2 dose regimens of 4 monthly IM doses of a new formulation (F006) of TMC278LA., To determine the safety, (local) tolerability and long-term plasma exposure over time of 1 dose regimen of 4 monthly subcutaneous (SC) doses of a new formulation (F006) of TMC278LA.

NCT ID: NCT00144833 Terminated - HIV-1 Clinical Trials

Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects

Start date: March 2005
Phase: Phase 3
Study type: Interventional

For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.