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Completed

NCT Number: NCT00685191

HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital U. Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.
  • Subjects initiating raltegravir plus another fully active antiretroviral drug.

Exclusion criteria

  • Pregnancy, or fertile women willing to be pregnant.
  • Active substance abuse or major psychiatric disease.

Treatment and study plan

Salvage antiretroviral therapy including raltegravir

Drug

Initiation of raltegravir-including salvage antiretroviral therapy

Other names: RAL

Primary outcomes

  1. Change in viral load from day 0 to 7

    Time frame: 1 week

Secondary outcomes

  1. Intracellular levels of HIV-1 proviral DNA and LTR circles

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 28, 2008
Registry last updated
Dec 4, 2019

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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