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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00685191

Enrollment

Registered

2008-05-28

Start date

2008-06-30

Completion date

2009-10-31

Last updated

2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Raltegravir, HIV, dynamics, viral load, Treatment Experienced

Brief summary

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.

Detailed description

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.

Interventions

DRUGSalvage antiretroviral therapy including raltegravir

Initiation of raltegravir-including salvage antiretroviral therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in viral load from day 0 to 7	1 week

Secondary

Measure	Time frame
Intracellular levels of HIV-1 proviral DNA and LTR circles	24 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026