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Completed

NCT Number: NCT00979706

Immune-based Therapy Pilot Study for the Treatment of Primary HIV Infection (PHI-IMD).

Pilot study for the treatment of primary HIV infection with the objective to induce a strong specific HIV immune response able to control viral replication without HAART.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

About this study

Pilot and open RCT in 20 patients with primary HIV-1 infection who were randomized to one of these two arms: 1) Control arm (A), Tenofovir +Lamivudine + Lopinavir-ritonavir (Kaletra) at standard doses for 44 weeks (W44); a short treatment interruption (TI) was performed at W36, and HAART was restarted for 8 weeks when plasma HIV-1 RNA viral load (pVL) rebounded>200 copies/mL. At W44 HAART was stopped and patients were followed for 48 additional weeks (W92). 2) Immune-based arm (B), same HAART schedule plus oral cyclosporine A (CsA)(serum levels 250-350 mcg/L) for the first 8 weeks of HAART. During the TI, patients received sc GM-CSF (250 mcg TIW) plus weekly sc pegylated-interferon a2b (Peg-INF)(1.5 mcg/kg/week). During the last 8 weeks of HAART (until W44), patients received daily sc low-dose interleukin-2 (IL-2)(0.75 MU/kg QD). The primary endpoint was pVL <1000copies/mL (<3.0 log10/mL) at 12 (W56) and at 48 (W92) weeks after stopping HAART. Sample size was calculated in order to detect a pVL difference of 1.5log10 copies/mL at 12 (W56) weeks after stopping HAART between the control and the immune-based arms with a power of 80% and a level of significance of0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-infected patients (age 18 years or over) with primary HIV infection <90 days.
  • Giving written informed consent to participate into the study.

Exclusion criteria

  • Patients not accepting to start HAART. Patients wishing start HAART treatment with nevirapine or efavirenz.
  • Pregnant women or planning pregnancy.
  • Intravenous drug user or alcohol abuse.
  • Previous treatment with cyclosporin A, GM-CSF,pegylated-interferon-alpha o interleukine-2.
  • Renal or liver failure.
  • Any formal contraindication to treatment with the study drugs.
  • Patients with a history of psychiatric disorder, thyroid illness, dislipidemia requiring treatment, cardiovascular disease, arterial hypertension, or diabetes mellitus.
  • In treatment with drugs interacting with study drugs.
  • Acute infection for HTLV-I or EBV.

Treatment and study plan

HAART

Drug

Patients assigned to this arm will receive Trizivir and kaletra. After the first 9 months of HAART, all patients will stop HAART until HIV viral load in plasma became detectable (>200 copies/mL). Then, they will re-start HAART plus low doses of IL-2 during 2 months.

All patients will be followed-up during 1 year.

Other names: Viread, Epivir, Kaletra

HAART + Immunotherapy

Drug

Patients assigned to this arm will receive Trizivir + Kaletra + cyclosporin A during the first two months. This group also will receive GM-CSF plus pegylated-interferon-alpha until HIV viral load in plasma became detectable (>200 copies/mL). Then, they will re-start HAART plus low doses of IL-2 during 2 months. At this moment they will stop HAART.

All patients will be followed-up during 1 year.

Other names: Cyclosporine A, GM-CSF, Peg-IFN, Interleukin-2

Primary outcomes

  1. Proportion of patients remaining below 5,000 copies/mL at 12 and 48 weeks after stoping HAART.

    Time frame: W12 y W48

Secondary outcomes

  1. Adherence to treatment

    Time frame: W8, W24, W36, W96

  2. CD4, CD8

    Time frame: W8, W24, W36, W96

  3. Specific HIV immune responses (CD4 and CTL)

    Time frame: W8, W24, W36, W96

  4. Proportion of patients PVL (plasma viral load)<40

    Time frame: W8, W24, W36, W96

  5. Adverse events

    Time frame: W8, W24, W36, W96

Sponsors and collaborators

Lead sponsor

Juan A. Arnaiz

Other

Registry information

Official study title

Immune-based Therapy Pilot Study for the Treatment of Primary HIV Infection With the Objective to Induce a Strong Specific HIV Immune Response Able to Control Viral Replication Without Highly Active Anti-Retroviral Therapy (HAART)

Acronym: PHI-IMD

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Sep 18, 2009
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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