Phase IV, multicenter, randomized, open-label pilot study of Truvada or Emtricitabine alone versus HAART interruption in HIV-infected patients who need to interrupt HAART and who are infected with HIV isolates containing at least 2 TAMs (or K65R) and M184V (GMB Study).Estudio piloto, multicéntrico y aleatorizadode fase IV, de Truvada o emtricitabina solos frente a la suspensión del TARGA en pacientes infectados por el VIH-1 que deciden interrumpir el TARGA y que están infectados por cepas del VIH-1 que contienen como mínimo 2 TAM (o K65R) y M184V (estudio GMB) - GMB

Phase 1

• Conditions: Human Immunodeficiency Virus (HIV-1) infection; MedDRA version: 8.1Level: PTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2005-004654-28-ES
• Lead Sponsor: Gilead Sciences, S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-28
• Study Completion: 2008-12-03
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

•HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive PCR for HIV-1 RNA.
•Adult patients (over 18 years of age).
•Available genotype (current or historical) showing M184V and (= 2 TAMs or K65R)
•CD4 cell count =350 cells/mL
•Patient request to stop HAART due to any of the following:

1) Patient is receiving a suppressive HAART regimen but has problems with adherence, quality of life or toxicity AND there is no alternative simpler, less toxic regimen (typically patients with substantial resistance and good virological control while receiving multiple antiretrovirals).
2) Due to resistance, patient is receiving a non-suppressive HAART regimen but patient is not willing to change to a new, already available, more complicated optimized salvage regimen (typically 3rd or 4th line of therapy).

•For women of childbearing potential, negative urine pregnancy test at screening visit.
•Agreement to take part in the study and sign the informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients receiving a non-registered antiretroviral (ARV) drug.
•Patients who have < 50 HIV-RNA copies/mL while receiving an NNRTI.
•Serum HBsAg positive and patient is receiving an anti-HBV active nucleoside/nucleotide.
•Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of these drugs.
•Known history of drug abuse or chronic alcohol consumption that in clinician opinion contraindicates participation in the study
•Women who are pregnant or breast feeding or females of childbearing potential who do not use an adequate method of contraception according to the investigator’s judgment.
•Current active opportunistic infection or documented infection within the previous 4 weeks.
•Documented active malignant disease (excluding Kaposi sarcoma limited to the skin).
•Renal disease with creatinine clearance < 50 mL/min.
•Concomitant use of nephrotoxic or immuno-suppressive drugs (should be stopped prior to enrollment)
•Receiving on-going therapy with systemic corticosteroids, Interleukin-2 (IL-2) or chemotherapy.
•Patients who are not to be included in the study according to the investigator’s criterion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified