NCT00362687

Brief Summary

Many patients who already harbor drug-resistant HIV require interruption of HAART due to poor compliance, poor quality of life, toxicity or development of resistance. In these patients interruption of HAART has a negative impact on patient immune status due to the reemergence of wild-type virus which is in general more pathogenic than HIV isolates containing resistance mutations. There is a need for "bridging" antiretroviral regimens that might prolong time off conventional HAART whilst waiting for a new regimen that is either fully suppressive or less toxic or less demanding for the patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

1.5 years

First QC Date

August 9, 2006

Last Update Submit

March 30, 2009

Conditions

HIV Infections

Keywords

HIV, HAART

Outcome Measures

Primary Outcomes (1)

  • To compare CD4 cell loses 24 weeks after HAART discontinuation

    Through 48 weeks

Secondary Outcomes (13)

  • Proportion of patients with re-initiation of HAART within 24 and 48 weeks

    Through 48 weeks

  • To compare CD4 cell loses 48 weeks after HAART discontinuation

    Through 48 weeks

  • To compare HIV viral loads 4, 24 and 48 weeks after HAART discontinuation:time-weighted average change from baseline through 24 and 48 weeks (DAVG24 and DAVG48) for log10 plasma HIV-1 RNA for patients with plasma HIV-1 RNA >50 copies/mL at baseline

    Through 48 weeks

  • To compare HIV viral loads 4, 24 and 48 weeks after HAART discontinuation: time-weighted average change from 4 weeks through 24 and 48 weeks (DAVG24 and DAVG48) for log10 plasma HIV-1 RNA for patients with <50 copies/mL at baseline

    Through 48 weeks

  • To compare HIV viral loads 4, 24 and 48 weeks after HAART discontinuation: proportion of patients with HIV RNA <400 and <50 copies/mL at 4 weeks for subjects with plasma HIV-1 RNA <50 copies/mL at baseline

    Through 48 weeks

  • +8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Truvada 1 tablet once a day.

Drug: Truvada (TDF+FTC) aloneProcedure: No HAART

2

EXPERIMENTAL

Emtricitabine 1 capsule once a day

Drug: FTC aloneProcedure: No HAART

Interventions

Truvada (TDF+FTC) aloneDRUG

tenofovir DF 300 mg and emtricitabine 200 mg in a fixed dose tablet formulation

1
FTC aloneDRUG

emtricitabine 200 mg

2
No HAARTPROCEDURE

No HAART

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 HAART interruption due to any of the following:
  • 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).
  • 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.

You may not qualify if:

  • 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 the 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilead Sciences, S.L.

Madrid, E-28036, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationSingle Person

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

TenofovirOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical PreparationsMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Pedro Ferrer

    Gilead Sciences, S.L.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 10, 2006

Study Start

November 1, 2006

Primary Completion

May 1, 2008

Study Completion

October 1, 2008

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

ES(1)