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Completed

NCT Number: NCT01869634

Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART

Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.

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Key information

Conditions

Human Immunodeficiency Virus Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California Davis

Sacramento, California, 95617, United States

About this study

Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to sign consent form
  • Naïve to ART (remote ART use >5 years will be considered on a case by case basis)
  • No known GI or cardiovascular disease
  • Between the ages of 18 and 60
  • No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness.
  • All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures.
  • Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease
  • There are no CD4+ T-cell count or HIV plasma viral load restrictions.

Exclusion criteria

  • Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN))
  • Thrombocytopenia (platelet count <50.000 within 6 weeks)
  • Contra-indications to upper endoscopy or conscious sedation
  • Anemia (>grade 1 [appendix 1])
  • Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.
  • Renal insufficiency (serum Creatinine >1.2 ULN)
  • History of chronic proteinuria that could impact viread use.
  • Allergy to contrast used for CT angiography
  • Requirement to take medications that are contraindicated with study ART regimen.

Treatment and study plan

darunavir with ritonavir and fixed-dose viread+emtricitabine daily

Drug

Other names: darunavir (Prezista®) 800 mg with ritonavir 100 mg and Truvada® to be taken once daily

Primary outcomes

  1. Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV

    Time frame: Baseline, 12 months

    CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.

Secondary outcomes

  1. Change in Percentage of Total Artery Diameter

    Time frame: Baseline, 12 months

    computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy

Other outcomes

  1. Change in Systemic Immune Activation

    Time frame: Baseline, 12 months

    Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6).

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 5, 2013
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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