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

Germans Trias i Pujol Hospital

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Salvage antiretroviral therapy including raltegravir

Study type: Interventional

Funder types: Other

Identifiers

NCT00685191

ITHACA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

1

Experimental group

Description:

HIV-1-infected subjects initiating raltegravir-including salvage therapy

Treatment:

Drug: Salvage antiretroviral therapy including raltegravir