HIV-1 Clinical Trial
Official title:
Prospective Evaluation of Body Composition, Bone Health and Hormonal Status After Initiation of an Integrase-inhibitor-based Anti-retroviral Therapy in Treatment-naïve HIV-1-infected Individuals
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.
Patients will be included at the initiation of cART. The follow up for this study is planned
to fit within the routine follow up consultations and includes some extra experimental
investigations, such as the medical body composition measurements, resting energy expenditure
measurement, Achilles bone ultrasonometer and DXA scans. Standard blood and urine samples
will be taken, including standard analyses and some extra analyses for the study.
Physical activity will be monitored for 5 consecutive days using a bracelet device while
patients will be asked to record their food intake using a standardized diet agenda.
Total follow up time will be 144 weeks and includes 12 visits in total.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01968551 -
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
|
Phase 3 | |
| Completed |
NCT02547844 -
Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla
|
Phase 4 | |
| Terminated |
NCT01345630 -
Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
|
Phase 3 | |
| Terminated |
NCT01173276 -
Intrauterine Insemination In HIV-Discordant Couples
|
N/A | |
| Completed |
NCT00807443 -
Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1
|
Phase 2 | |
| Completed |
NCT01140139 -
Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions
|
Phase 1 | |
| Withdrawn |
NCT00340223 -
HLA-B35 Alleles and AIDS
|
N/A | |
| Completed |
NCT00097006 -
Retrovirus Epidemiology Donor Study-II (REDS-II)
|
N/A | |
| Completed |
NCT02217904 -
A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
|
Phase 1 | |
| Completed |
NCT00772902 -
ROCKET II - Randomized Open Label Switch for Cholesterol Elevation on Kivexa + Kaletra Evaluation Trial
|
Phase 4 | |
| Completed |
NCT04006704 -
Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets
|
Phase 1 | |
| Terminated |
NCT03060629 -
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
|
Phase 2 | |
| Recruiting |
NCT00981695 -
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers
|
Phase 1/Phase 2 | |
| Completed |
NCT00982579 -
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers
|
Phase 1 | |
| Completed |
NCT01084343 -
Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects
|
Phase 1 | |
| Completed |
NCT00665847 -
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
|
Phase 2 | |
| Completed |
NCT00098293 -
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
|
Phase 3 | |
| Recruiting |
NCT05944848 -
A Study of CL-197 Capsules in Healthy Participants
|
Phase 1 | |
| Completed |
NCT00479999 -
Phase 1 Safety Study of Two Experimental HIV Vaccines
|
Phase 1 | |
| Completed |
NCT01274780 -
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients
|
Phase 4 |