GMB: Study of Truvada (TDF+FTC) or Emtricitabine (FTC) Alone Versus HAART Interruption in HIV-Infected Patients With Resistance

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

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 HAART interruption 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.

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 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.